M.U.S.T. PEDICLE SCREW SYSTEM

Additional Manufacturer Narrative

BATCH REVIEW PERFORMED ON 03 JULY 2026 03.52.358 ENH POLY-AXIAL PEDICLE SCREW - CANNULATED 8X80MM (K203482) LOT. 2564193: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09 OCTOBER 2025. EXPIRATION DATE: 22 SEPTEMBER 2030. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. 03.52.326 ENH. CANN. PEDICLE SCREW 6X55MM + NUT (1X) STERILE (K141988) LOT. 2659304: (B)(4) ITEMS MANUFACTURED AND RELEASED ON NAN. EXPIRATION DATE: 29 MARCH 2031. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. 03.52.325 ENH. CANN. PEDICLE SCREW 6X50MM + NUT (1X) STERILE (K141988) LOT. 2658258: (B)(4) ITEMS MANUFACTURED AND RELEASED ON NAN. EXPIRATION DATE: 19 FEBRUARY 2031. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. 03.52.325 ENH. CANN. PEDICLE SCREW 6X50MM + NUT (1X) STERILE (K141988) LOT. 2658257: (B)(4) ITEMS MANUFACTURED AND RELEASED ON NAN. EXPIRATION DATE: 22 FEBRUARY 2031. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. 03.52.324 ENH. CANN. PEDICLE SCREW 6X45MM + NUT (1X) STERILE (K141988) LOT. 2120352A: (B)(4) ITEMS MANUFACTURED AND RELEASED ON NAN. EXPIRATION DATE: 10 FEBRUARY 2031. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. 03.52.339 ENH. CANN. PEDICLE SCREW 7X50MM + NUT (1X) STERILE (K141988) LOT. 2562634: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27 AUGUST 2025. EXPIRATION DATE: 09 JULY 2030. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. 03.52.324 ENH. CANN. PEDICLE SCREW 6X45MM + NUT (1X) STERILE (K141988) LOT. 2657674: (B)(4) ITEMS MANUFACTURED AND RELEASED ON NAN. EXPIRATION DATE: 09 FEBRUARY 2031. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. 03.52.324 ENH. CANN. PEDICLE SCREW 6X45MM + NUT (1X) STERILE (K141988) LOT. 2566406: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09 DECEMBER 2025. EXPIRATION DATE: 09 NOVEMBER 2030. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. 03.52.314 ENH. CANN. PEDICLE SCREW 5X40MM + NUT (1X) STERILE (K141988) LOT. 2657450: (B)(4) ITEMS MANUFACTURED AND RELEASED ON NAN. EXPIRATION DATE: 27 JANUARY 2031. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. 03.52.314 ENH. CANN. PEDICLE SCREW 5X40MM + NUT (1X) STERILE (K141988) LOT. 2568593: (B)(4) ITEMS MANUFACTURED AND RELEASED ON NAN. EXPIRATION DATE: 19 JANUARY 2031. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. 03.52.312 ENH. CANN. PEDICLE SCREW 5X30MM + NUT (1X) STERILE (K141988) LOT. 2658251: (B)(4) ITEMS MANUFACTURED AND RELEASED ON NAN. EXPIRATION DATE: 23 FEBRUARY 2031. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. 03.52.323 ENH. CANN. PEDICLE SCREW 6X40MM + NUT (1X) STERILE (K141988) LOT. 2657453: (B)(4) ITEMS MANUFACTURED AND RELEASED ON NAN. EXPIRATION DATE: 25 JANUARY 2031. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. 03.52.305 ENH.CANN.PEDICLE SCREW 4.5X40MM + NUT (1X) STERILE (K171170) LOT. 2461512: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02 AUGUST 2024. EXPIRATION DATE: 16 JULY 2029. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. 03.52.305 ENH.CANN.PEDICLE SCREW 4.5X40MM + NUT (1X) STERILE (K171170) LOT. 2462450: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20 SEPTEMBER 2024. EXPIRATION DATE: 04 SEPTEMBER 2029. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. 03.52.304 ENH.CANN.PEDICLE SCREW 4.5X35MM + NUT (1X) STERILE (K171170) LOT. 2567472: (B)(4) ITEMS MANUFACTURED AND RELEASED ON NAN. EXPIRATION DATE: 18 DECEMBER 2030. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. 03.52.303 ENH.CANN.PEDICLE SCREW 4.5X30MM + NUT (1X) STERILE (K171170) LOT. 2566400: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09 JANUARY 2026. EXPIRATION DATE: 17 NOVEMBER 2030. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ROOT CAUSE:ALTHOUGH A DEFINITIVE ROOT CAUSE COULD NOT BE ESTABLISHED BASED ON THE AVAILABLE INFORMATION, THE HISTORICAL RECORDS OF ALL POTENTIALLY INVOLVED PEDICLE SCREWS DID NOT REVEAL ANY DISCREPANCIES. THEREFORE, BASED ON THE AVAILABLE EVIDENCE, THE EVENT MAY BE RELATED TO INADEQUATE TIGHTENING DURING THE PRIMARY SURGERY.

Description of Event or Problem

DURING A FOLLOW-UP VISIT TWO WEEKS AFTER SURGERY, THE SET SCREW WAS FOUND TO BE LOOSE. REVISION SURGERY WAS COMPLETED SUBSTITUTING THE SET SCREW.