NA 388.61Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10705034773612), received between Jun 6, 2017 and Aug 20, 2025 — classified as 1 injury, 16 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (6 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 20, 2025Mechanical Problem; Compatibility Problem; Material Integrity Problem; Mechanical Problem; Compatibility Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE PERSUADER TUBE, WHERE THE COLLAR CONNECTS, IS LOOSE AND THE SCREW TO TIGHTEN IT IS STRIPPED. ALSO, THE USS SCREW HOLDER IS STRIPPED AND WILL NOT CONNECT TO SCREWS. THERE WAS NO SURGICAL DELAY. THE PROCEDURE COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22850325 ↗
• MalfunctionMay 16, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED DURING INSPECTION, THE HOSPITAL DISCOVERED THAT ONE OF THE ITEMS WAS SOILED IN THE SET. CUSTOMER WASHED THE ITEM FOR IMMEDIATE USE. THIS REPORT IS FOR ONE HOOK OR SCREW HOLDER THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19335469 ↗
• MalfunctionNov 19, 2020Compatibility Problem; Compatibility Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT A SCOLIOSIS T10-L5 FUSION PROCEDURE. UPON INSPECTION, DURING SETUP, IT WAS NOTICED THAT THE HANDLES OF TWO (2) SOCKET WRENCH WITH STRAIGHT HANDLE (WITH SILICONE HANDLE) HAD A RESIDUE OF WHITE POWDER IN THE CANNULA RESULTING IN THE ENTIRE STERILE FIELD BEING CONTAMINATED. DURING THE SURGERY, TWO (2) ROD INTRODUCTION PLIERS WERE USED AND ENDED UP GETTING STUCK INSIDE A HOOK/ SCREW HOLDER AND THE HANDLE OF A SOCKET WRENCH WITH STRAIGHT HANDLE DISINTEGRATED UPON ROUTINE TIGHTENING. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A THIRTY (30) MINUTE SURGICAL DELAY. THE PATIENT'S STATUS IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN NUT (PART #: UNKNOWN, LOT #: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR ONE (1) HOOK OR SCREW HOLDER. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10868527 ↗
• MalfunctionAug 25, 2020Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING A ROUTINE INSPECTION OF CONSIGNMENT SETS THE FOLLOWING USS HANDLES FOR HOOK OR SCREW HOLDER WERE FOUND TO BE NOT FUNCTIONING PROPERLY. THE GRAY TOP OF THE HANDLE DOES NOT TURN THE "IMPLANT HOLDER". THEY BELIEVE THAT THE SET SCREW ON THE GRAY KNOB OF THE HANDLE FOR HOOK OR SCREW HOLDER IS NOT ADEQUATELY ENGAGING IN THE INNER SHAFT OF THE INSTRUMENT. THE REPORTER REFERRED TO IMPLANT HOLDER WAS THE SCREW HOLDER. THE INNER SHAFT IS AN INTERNAL PART IN THE HANDLE FOR HOOK OR SCREW HOLDER. THERE WAS NO PATIENT INVOLVEMENT. CONCOMITANT DEVICE REPORTED: USS HOOK AND SCREW HOLDER (PART # 388.610, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) HOOK OR SCREW HOLDER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10451251 ↗
• MalfunctionJun 20, 2019Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SURGEON MENTIONED THE LAST TIME THE UNIVERSAL SPINAL SYSTEM (USS) WERE USED, THE FOLLOWING INSTRUMENTS WERE NOT FUNCTIONING. UPON INSPECTION IT IS CLEAR THAT THE TWO (2) HANDLE FOR HOOK/SCREW HOLDER DON'T HOLD THE STICKS, EIGHT (8) STICKS/HOOK ARE BENT, AND TWO (2) PERSUADERS/ROD INTRODUCTION PLIERS AREN'T REDUCING PROPERLY, ONE (1) BEND TEMPLATE FOR ROD UNSPECIFIED MALFUNCTION, AND TWO (2) SOCKET WRENCH WITH STRAIGHT HANDLE UNSPECIFIED MALFUNCTION. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT (B)(4) CAPTURES 2 DEVICES AND COMPLAINT (B)(4) CAPTURES 13 DEVICES. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8717598 ↗
• MalfunctionJun 20, 2019Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SURGEON MENTIONED THE LAST TIME THE UNIVERSAL SPINAL SYSTEM (USS) WERE USED, THE FOLLOWING INSTRUMENTS WERE NOT FUNCTIONING. UPON INSPECTION IT IS CLEAR THAT THE TWO (2) HANDLE FOR HOOK/SCREW HOLDER DON'T HOLD THE STICKS, EIGHT (8) STICKS/HOOK ARE BENT, AND TWO (2) PERSUADERS/ROD INTRODUCTION PLIERS AREN'T REDUCING PROPERLY, ONE (1) BEND TEMPLATE FOR ROD UNSPECIFIED MALFUNCTION, AND TWO (2) SOCKET WRENCH WITH STRAIGHT HANDLE UNSPECIFIED MALFUNCTION. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT (B)(4) CAPTURES 2 DEVICES AND COMPLAINT (B)(4) CAPTURES 13 DEVICES. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8717512 ↗
• MalfunctionJun 20, 2019Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SURGEON MENTIONED THE LAST TIME THE UNIVERSAL SPINAL SYSTEM (USS) WERE USED, THE FOLLOWING INSTRUMENTS WERE NOT FUNCTIONING. UPON INSPECTION IT IS CLEAR THAT THE TWO (2) HANDLE FOR HOOK/SCREW HOLDER DON'T HOLD THE STICKS, EIGHT (8) STICKS/HOOK ARE BENT, AND TWO (2) PERSUADERS/ROD INTRODUCTION PLIERS AREN'T REDUCING PROPERLY, ONE (1) BEND TEMPLATE FOR ROD WAS ILLEGIBLE, AND TWO (2) SOCKET WRENCH WITH STRAIGHT HANDLE WERE CRACKED. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES TOTAL 15 DEVICES. THIS COMPLAINT (B)(4) CAPTURES 13 DEVICES, REMAINING 2 DEVICES ARE CAPTURED UNDER RELATED COMPLAINT (B)(4). THIS REPORT IS FOR ONE (1) HOOK OR SCREW HOLDER. THIS IS REPORT 6 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8716599 ↗
• MalfunctionJun 20, 2019Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SURGEON MENTIONED THE LAST TIME THE UNIVERSAL SPINAL SYSTEM (USS) WERE USED, THE FOLLOWING INSTRUMENTS WERE NOT FUNCTIONING. UPON INSPECTION IT IS CLEAR THAT THE TWO (2) HANDLE FOR HOOK/SCREW HOLDER DON'T HOLD THE STICKS, EIGHT (8) STICKS/HOOK ARE BENT, AND TWO (2) PERSUADERS/ROD INTRODUCTION PLIERS AREN'T REDUCING PROPERLY, ONE (1) BEND TEMPLATE FOR ROD WAS ILLEGIBLE, AND TWO (2) SOCKET WRENCH WITH STRAIGHT HANDLE WERE CRACKED. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES TOTAL 15 DEVICES. THIS COMPLAINT (B)(4) CAPTURES 13 DEVICES, REMAINING 2 DEVICES ARE CAPTURED UNDER RELATED COMPLAINT (B)(4) THIS REPORT IS FOR ONE (1) HOOK OR SCREW HOLDER. THIS IS REPORT 5 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8716580 ↗
• MalfunctionJun 20, 2019Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SURGEON MENTIONED THE LAST TIME THE UNIVERSAL SPINAL SYSTEM (USS) WERE USED, THE FOLLOWING INSTRUMENTS WERE NOT FUNCTIONING. UPON INSPECTION IT IS CLEAR THAT THE TWO (2) HANDLE FOR HOOK/SCREW HOLDER DON'T HOLD THE STICKS, EIGHT (8) STICKS/HOOK ARE BENT, AND TWO (2) PERSUADERS/ROD INTRODUCTION PLIERS AREN'T REDUCING PROPERLY, ONE (1) BEND TEMPLATE FOR ROD WAS ILLEGIBLE, AND TWO (2) SOCKET WRENCH WITH STRAIGHT HANDLE WERE CRACKED. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES TOTAL 15 DEVICES. (B)(4). THIS REPORT IS FOR ONE (1) HOOK OR SCREW HOLDER. THIS IS REPORT 4 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8716564 ↗
• MalfunctionJun 20, 2019Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SURGEON MENTIONED THE LAST TIME THE UNIVERSAL SPINAL SYSTEM (USS) WERE USED, THE FOLLOWING INSTRUMENTS WERE NOT FUNCTIONING. UPON INSPECTION IT IS CLEAR THAT THE TWO (2) HANDLE FOR HOOK/SCREW HOLDER DON'T HOLD THE STICKS, EIGHT (8) STICKS/HOOK ARE BENT, AND TWO (2) PERSUADERS/ROD INTRODUCTION PLIERS AREN'T REDUCING PROPERLY, ONE (1) BEND TEMPLATE FOR ROD WAS ILLEGIBLE, AND TWO (2) SOCKET WRENCH WITH STRAIGHT HANDLE WERE CRACKED. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES TOTAL 15 DEVICES. THIS COMPLAINT (B)(4) CAPTURES 13 DEVICES, REMAINING 2 DEVICES ARE CAPTURED UNDER RELATED COMPLAINT (B)(4). THIS REPORT IS FOR ONE (1) HOOK OR SCREW HOLDER. THIS IS REPORT 3 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8716533 ↗
• MalfunctionJun 20, 2019Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SURGEON MENTIONED THE LAST TIME THE UNIVERSAL SPINAL SYSTEM (USS) WERE USED, THE FOLLOWING INSTRUMENTS WERE NOT FUNCTIONING. UPON INSPECTION IT IS CLEAR THAT THE TWO (2) HANDLE FOR HOOK/SCREW HOLDER DON'T HOLD THE STICKS, EIGHT (8) STICKS/HOOK ARE BENT, AND TWO (2) PERSUADERS/ROD INTRODUCTION PLIERS AREN'T REDUCING PROPERLY, ONE (1) BEND TEMPLATE FOR ROD WAS ILLEGIBLE, AND TWO (2) SOCKET WRENCH WITH STRAIGHT HANDLE WERE CRACKED. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES TOTAL 15 DEVICES. THIS COMPLAINT (B)(4) CAPTURES 13 DEVICES, REMAINING 2 DEVICES ARE CAPTURED UNDER RELATED COMPLAINT (B)(4). THIS REPORT IS FOR ONE (1) HOOK OR SCREW HOLDER. THIS IS REPORT 2 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8716524 ↗
• MalfunctionJun 20, 2019Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SURGEON MENTIONED THE LAST TIME THE UNIVERSAL SPINAL SYSTEM (USS) WERE USED, THE FOLLOWING INSTRUMENTS WERE NOT FUNCTIONING. UPON INSPECTION IT IS CLEAR THAT THE TWO (2) HANDLE FOR HOOK/SCREW HOLDER DON'T HOLD THE STICKS, EIGHT (8) STICKS/HOOK ARE BENT, AND TWO (2) PERSUADERS/ROD INTRODUCTION PLIERS AREN'T REDUCING PROPERLY, ONE (1) BEND TEMPLATE FOR ROD WAS ILLEGIBLE, AND TWO (2) SOCKET WRENCH WITH STRAIGHT HANDLE WERE CRACKED. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES TOTAL 15 DEVICES. THIS COMPLAINT (B)(4) CAPTURES 13 DEVICES, REMAINING 2 DEVICES ARE CAPTURED UNDER RELATED COMPLAINT (B)(4). THIS REPORT IS FOR ONE (1) HOOK OR SCREW HOLDER. THIS IS REPORT 1 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8716464 ↗
• InjuryApr 13, 2018Break; Break

  IT WAS REPORTED DURING A REVISION SURGERY THAT THE REMOVAL OF S1 SCREWS THAT TWO IMPLANT HOLDERS BROKE. ADDITIONALLY, WHILE REPLACING THE RIGHT S1 SCREW, TWO UNIVERSAL SPINE SYSTEM-VARIABLE ANGLE SCREWS (USS-VAS) BROKE - (THE LOCKING RING ON THE SCREW BECAME DISLODGED AND WOULD NOT WORK). A THIRD IMPLANT HOLDER BROKE DURING FINAL TIGHTENING, AND A TIP OF THE HOLDER BROKE OFF INTO THE LEFT S1 SCREW AND WAS NOT RETRIEVABLE. IT REMAINED IN THE PATIENT. WHILE INSPECTING THE USS-VAS SCREWDRIVERS, IT WAS DISCOVERED THAT THE TIPS OF THE DRIVERS WERE TWISTED. REPLACEMENTS WERE REQUESTED. THE REVISION SURGERY WAS CAPTURED AS A POSTOPERATIVE EVENT ON A RELATED PRODUCT COMPLAINT (B)(4). CONCOMITANT DEVICES REPORTED: UNKNOWN USS SCREWS (PART UNKNOWN, LOT UNKNOWN, QUANTITY 3). THIS IS REPORT 3 OF 7 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 7429705 ↗
• MalfunctionApr 13, 2018Break; Break

  IT WAS REPORTED DURING A REVISION SURGERY THAT THE REMOVAL OF S1 SCREWS THAT TWO IMPLANT HOLDERS BROKE. ADDITIONALLY, WHILE REPLACING THE RIGHT S1 SCREW, TWO UNIVERSAL SPINE SYSTEM-VARIABLE ANGLE SCREWS (USS-VAS) BROKE - (THE LOCKING RING ON THE SCREW BECAME DISLODGED AND WOULD NOT WORK). A THIRD IMPLANT HOLDER BROKE DURING FINAL TIGHTENING, AND A TIP OF THE HOLDER BROKE OFF INTO THE LEFT S1 SCREW AND WAS NOT RETRIEVABLE. IT REMAINED IN THE PATIENT. WHILE INSPECTING THE USS-VAS SCREWDRIVERS, IT WAS DISCOVERED THAT THE TIPS OF THE DRIVERS WERE TWISTED. REPLACEMENTS WERE REQUESTED. THE REVISION SURGERY WAS CAPTURED AS A POSTOPERATIVE EVENT ON A RELATED PRODUCT COMPLAINT (B)(4). CONCOMITANT DEVICES REPORTED: UNKNOWN USS SCREWS (PART UNKNOWN, LOT UNKNOWN, QUANTITY 3). THIS IS REPORT 1 OF 7 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7429657 ↗
• MalfunctionApr 13, 2018Break; Break

  IT WAS REPORTED DURING A REVISION SURGERY THAT THE REMOVAL OF S1 SCREWS THAT TWO IMPLANT HOLDERS BROKE. ADDITIONALLY, WHILE REPLACING THE RIGHT S1 SCREW, TWO UNIVERSAL SPINE SYSTEM-VARIABLE ANGLE SCREWS (USS-VAS) BROKE - (THE LOCKING RING ON THE SCREW BECAME DISLODGED AND WOULD NOT WORK). A THIRD IMPLANT HOLDER BROKE DURING FINAL TIGHTENING, AND A TIP OF THE HOLDER BROKE OFF INTO THE LEFT S1 SCREW AND WAS NOT RETRIEVABLE. IT REMAINED IN THE PATIENT. WHILE INSPECTING THE USS-VAS SCREWDRIVERS, IT WAS DISCOVERED THAT THE TIPS OF THE DRIVERS WERE TWISTED. REPLACEMENTS WERE REQUESTED. THE REVISION SURGERY WAS CAPTURED AS A POSTOPERATIVE EVENT ON A RELATED PRODUCT COMPLAINT (B)(4). CONCOMITANT DEVICES REPORTED: UNKNOWN USS SCREWS (PART UNKNOWN, LOT UNKNOWN, QUANTITY 3). THIS IS REPORT 2 OF 7 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7429655 ↗
• MalfunctionJun 6, 2017Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2014, THE PATIENT UNDERWENT A L5-S1 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) WITH THE SYNTHES SYNFIX-LR DEVICE. IT WAS REPORTED THAT ACCORDING TO THE PHYSICIAN, THE PATIENT NEVER DEVELOPED A SOLID FUSION AFTER THE INITIAL SURGERY AND THAT THE PATIENT HAD RADICULAR PAIN. REPORTEDLY, PATIENT HAD RADICULOPATHY. NO ISSUES WITH THE SYNFIX-LR HARDWARE WERE REPORTED. THE SURGEON PLANNED TO PERFORM A POSTERIOR SPINAL FUSION WITH SYNTHES USS AND PERFORM A DECOMPRESSION. PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2017. DURING THE REVISION SURGERY, THE SURGEON PLACED THE L5-S1 USS SCREWS. WHILE INSERTING THE RIGHT S1 USS SCREW (498.866), THE TOP PART OF THE SCREW THAT ENGAGES THE ¿IMPLANT HOLDER / STICK 388.61¿ BROKE OFF. THIS PIECE WAS RETRIEVED. TWO OF THE 388.61 STICKS ALSO BROKE TRYING TO GET THE SCREW OUT ¿ THE TABS THAT ENGAGE THE TOP OF THE SCREW BROKE OFF. ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT. THERE WAS A TREMENDOUS AMOUNT OF TORQUE THAT WAS PLACED ON THE SCREW AND THE STICKS THAT CONTRIBUTED TO THE BREAKAGES. THE SURGEON THOUGHT THAT THE USS SCREW WAS HITTING ON THE SYNFIX SCREW IN S1 CONTRIBUTING TO THE HIGH TORQUE. HE THEN USED A

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6615006 ↗
• MalfunctionJun 6, 2017Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2014, THE PATIENT UNDERWENT A L5-S1 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) WITH THE SYNTHES SYNFIX-LR DEVICE. IT WAS REPORTED THAT ACCORDING TO THE PHYSICIAN, THE PATIENT NEVER DEVELOPED A SOLID FUSION AFTER THE INITIAL SURGERY AND THAT THE PATIENT HAD RADICULAR PAIN. REPORTEDLY, PATIENT HAD RADICULOPATHY. NO ISSUES WITH THE SYNFIX-LR HARDWARE WERE REPORTED. THE SURGEON PLANNED TO PERFORM A POSTERIOR SPINAL FUSION WITH SYNTHES USS AND PERFORM A DECOMPRESSION. PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2017. DURING THE REVISION SURGERY, THE SURGEON PLACED THE L5-S1 USS SCREWS. WHILE INSERTING THE RIGHT S1 USS SCREW (498.866), THE TOP PART OF THE SCREW THAT ENGAGES THE ¿IMPLANT HOLDER / STICK 388.61¿ BROKE OFF. THIS PIECE WAS RETRIEVED. TWO OF THE 388.61 STICKS ALSO BROKE TRYING TO GET THE SCREW OUT ¿ THE TABS THAT ENGAGE THE TOP OF THE SCREW BROKE OFF. ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT. THERE WAS A TREMENDOUS AMOUNT OF TORQUE THAT WAS PLACED ON THE SCREW AND THE STICKS THAT CONTRIBUTED TO THE BREAKAGES. THE SURGEON THOUGHT THAT THE USS SCREW WAS HITTING ON THE SYNFIX SCREW IN S1 CONTRIBUTING TO THE HIGH TORQUE. HE THEN USED A

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6614982 ↗