VBT SCREW, UNKNOWN SIZE

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR SPINAL FUSION WITH LUMBAR VERTEBRAL TETHER. UPON HER STANDING X-RAY ON POD 3, IT WAS NOTED TO LIST OFF AT THE L2-L3 AND L3-L4 VERTEBRA. PREVIOUSLY DURING THE IMPLANT SURGERY, THERE WAS CONCERN OF OVER CORRECTING HER LUMBAR CURVE. IN TURN, THE SLACK AT THE L2-L3 SEGMENT ALLOWED FOR TRANSLATION AND A 33-DEGREE CURVE. AFTER DISCUSSION WITH THE FAMILY, INCLUDING THE RISKS, BENEFITS, COMPLICATIONS, AND ALTERNATIVES, THE DECISION WAS MADE TO PROCEED WITH A REVISION TO RETIGHTEN THE TETHER L2-L4. AFTER RETIGHTENING THE TETHER, THE CURVE IMPROVED TO 25 DEGREES. THIS IS REPORT THREE OF FOUR FOR THIS EVENT.

Additional Manufacturer Narrative

PROCODE: QHP. WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT. REFERENCE REPORTS 3012447612-2022-00307 THROUGH 3012447612-2022-00310.

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR SPINAL FUSION WITH LUMBAR VERTEBRAL TETHER. UPON HER STANDING X-RAY ON POD 3, IT WAS NOTED TO LIST OFF AT THE L2-L3 AND L3-L4 VERTEBRA. PREVIOUSLY DURING THE IMPLANT SURGERY, THERE WAS CONCERN OF OVER CORRECTING HER LUMBAR CURVE. IN TURN, THE SLACK AT THE L2-L3 SEGMENT ALLOWED FOR TRANSLATION AND A 33-DEGREE CURVE. AFTER DISCUSSION WITH THE FAMILY, INCLUDING THE RISKS, BENEFITS, COMPLICATIONS, AND ALTERNATIVES, THE DECISION WAS MADE TO PROCEED WITH A REVISION TO RETIGHTEN THE TETHER L2-L4. AFTER RETIGHTENING THE TETHER, THE CURVE IMPROVED TO 25 DEGREES. THIS IS REPORT THREE OF FOUR FOR THIS EVENT.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION IN H6: COMPONENT, INVESTIGATION TYPE, FINDINGS, AND CONCLUSIONS. DEVICE EVALUATION: THE PRODUCTS WERE NOT RETURNED AND NO PHOTOS WERE PROVIDED, SO AN EVALUATION IS UNABLE TO BE PERFORMED. ROOT CAUSE: A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. THIS EVENT COULD POSSIBLY BE ATTRIBUTED TO PATIENT, SURGEON, OR SURGERY SPECIFIC FACTORS. DHR REVIEW: THE LOT NUMBERS WERE NOT PROVIDED, SO THE DHRS WERE UNABLE TO BE REVIEWED. DEVICE USAGE: THIS DEVICE IS USED FOR TREATMENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT, A FOLLOW-UP REPORT WILL BE SENT.