RESPONSE SET SCREW, LARGE

Additional Manufacturer Narrative

REFERENCE: (B)(4). REPORT SOURCE: (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ORTHOPEDIATRICS FOR INVESTIGATION AS IT REMAINS IMPLANTED. THE INVESTIGATION IS COMPLETED. DHR REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE WAS UNABLE TO BE DETERMINED.

Description of Event or Problem

IT HAS BEEN REPORTED THAT FOLLOWING THE PLACEMENT OF A SPINAL CONSTRUCT SYSTEM, A DISTAL SET SCREW WAS NOTED TO BE LOOSE. PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2019 TO REMOVE SET SCREW AND CORRESPONDING PEDICLE SCREW. DURING THE REVISION SURGERY, THE SURGEON IDENTIFIED A FRACTURED PEDICLE SCREW.

Additional Manufacturer Narrative

REFERENCE: (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. D11 UPDATED. CONCOMITTANT DEVICES REPORTED BY CUSTOMER: ITEM: 00-1003-4001 LOT: M93500-B UDI: (B)(4), DESCRIPTION: SET SCREW, LARGE. ITEM: 00-1003-4001 LOT: M93499-B UDI: (B)(4), DESCRIPTION: SET SCREW, LARGE. ITEM: 00-1003-4001 LOT: M93498-B UDI: (B)(4), DESCRIPTION: SET SCREW, LARGE. ITEM: 00-1003-4001 LOT: UNKNOWN UDI: UNKNOWN, DESCRIPTION: SET SCREW, LARGE. ITEM: 00-1300-0655 LOT:041820-E UDI: (B)(4), DESCRIPTION: 5.5/6.0 POLYAXIAL PEDICLE SCREW 6.0MM X 55MM. ITEM: 00-1300-0655 LOT: UNKNOWN UDI: UNKNOWN, DESCRIPTION: 5.5/6.0 POLYAXIAL PEDICLE SCREW 6.0MM X 55MM. H6: RESULT CODE UPDATED TO 3207 - 3252. H6 METHOD CODE UPDATED TO 3331. X-RAYS WERE REVIEWED AND COMPLAINT WAS CONFIRMED. DHR WAS REVIEWED AND RESULTS WERE INCONCLUSIVE. ROOT CAUSE WAS UNABLE TO BE DETERMINED.