RESPONSE UNIAXIAL PEDICLE SCREW

Additional Manufacturer Narrative

REFERENCE: (B)(4). COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL INSPECTION CONFIRMED THAT THE SCREW FRACTURED. INVESTIGATION OF THE DHR DID NOT REVEAL ANY PROCESS DEVIATIONS OR INDICATIONS OF MANUFACTURING VARIATIONS THAT WOULD CONTRIBUTE TO THE OBSERVED FAILURE MODE. THE SCREW WAS MADE TO SPECIFICATION, THERE HAD BEEN NO RECENT DESIGN CHANGES TO THE SCREW SHAFT, AND THERE ARE NO OTHER COMPLAINTS RELATED TO THIS PART NUMBER. THE ROOT CAUSE WAS UNABLE TO BE DETERMINED. "LOSS OF FIXATION OR IMPLANT BREAKAGE ATTRIBUTABLE TO DELAYED OR NON-UNION" IS A KNOWN ADVERSE EFFECT STATED IN THE DEVICE IFU. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ORTHOPEDIATRICS WILL CONTINUE TO MONITOR FOR TRENDS.

Description of Event or Problem

IT WAS REPORTED THAT FOLLOWING THE PLACEMENT OF A RESPONSE SPINE CONSTRUCT, A SCREW WAS FOUND TO BE FRACTURED AT A ONE-YEAR FOLLOW-UP. THE SURGEON BELIEVES THAT PSEUDARTHROSIS CAUSED THE FRACTURE OF THE SCREW. THE PATIENT UNDERWENT A REVISION PROCEDURE TO REPLACE THE FRACTURED SCREW. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.