In Support of Collaborative Pediatric Device Innovation—Reply

Дата публикации: 01-09-2026 00:00:00

In Reply It is essential that we learn from previous errors. This is not an indictment against anyone or any entity but a reality that physicians face each day. Confronting the known failures of the magnetically controlled growing rod (MAGEC) device or any device should never be labeled as “dangerous,” “chilling,” or “undermining,” as if it is a subversive act. Rather, it should be sought after as progress toward clarity and honesty with patients and physicians regarding the devices they choose to have implanted. Similarly, metal-on-metal hips were inappropriately authorized under the 510(k) pathway by demonstrating substantial equivalence to anachronistic devices, and they too had unexpected failures, metallosis, and subsequent recall. Valuable lessons were learned from accepting that failure and analyzing it. Approaching the MAGEC experience with the same critical reflection should be advocated for by our professional leaders, not discouraged.

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