USS 03.607.005Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10705034712895), received between Dec 21, 2016 and Aug 12, 2025 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Break” (10 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 12, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT IN THEATRE, WHEN USING THE KIT, ONE OF THE POSTS BROKE OFF IN THE SCREW HEAD INTRAOPERATIVELY. THE BROKEN PART WAS RETRIEVED FROM THE PATIENT. THIS DID NOT CAUSE ANY DELAY, AS THE SURGEON IS VERY EXPERIENCED WITH THIS KIT. THERE WERE ALTERNATIVE OPTIONS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22786674 ↗
• MalfunctionMar 14, 2022Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, DURING FINAL TIGHTENING OF THE POLYAXIAL SCREWS THERE WAS AN UNUSUAL "SCREECHING" SOUND WHILE TIGHTENING THE NUTS. THIS OCCURRED WITH APPROXIMATELY 50% OF SCREWS. THE SURGEON COMMENTED THAT IT SOUNDED LIKE THE SCREWS WERE CROSS THREADING IN A SIMILAR WAY TO PREVIOUS ISSUES THE SURGEON HAD HAD WITH THE USS POLYAXIAL HEADS. THIS NOISE WAS NOT OBSERVED WITH THE MONOAXIAL SCREWS USED. FINAL TIGHTENING WAS ACHIEVED AND THERE WAS A TEN (10) MINUTE DELAY TO THE CASE. DURING FINAL TIGHTENING ITEM THE USS-II POLYAXIAL SCREWHOLDER BROKE OFF IN ONE OF THE SCREW HEADS LEAVING A SMALL THREADED PORTION IN THE SCREW HEAD. THE FRAGMENT WAS RETRIEVED CAUSING APPROXIMATELY A TEN (10) MINUTE DELAY TO THE SURGERY. THIS REPORT INVOLVES ONE (1) POLYAXIAL HEAD HOLDER FOR USS POLYAXIAL. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13757104 ↗
• MalfunctionJan 6, 2022Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2021, USS-II POLYAXIAL SCREW HOLDER BROKE INTO 2 PARTS WHEN FASTENING TO SCREW HEAD. FRAGMENTS WERE GENERATED; HOWEVER NO PARTS REMAINED IN PATIENT'S BODY. THERE WAS NO PATIENT HARM NOR SIGNIFICANT DELAY. PROCEDURE FINISHED WITH SAME LIKE PRODUCT. THIS REPORT IS FOR ONE (1) POLYAXIAL HEAD HOLDER FOR USS POLYAXIAL THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13180544 ↗
• MalfunctionAug 26, 2021Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT IN (B)(6) 2020, THE TIP OF THE SCREWDRIVER BROKE OFF. NO FRAGMENTS WERE CREATED OR REMAINED IN THE PATIENT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH ANOTHER AVAILABLE INSTRUMENT. THERE WAS NO SURGICAL DELAY OR ADVERSE PATIENT HARM. THIS REPORT IS FOR ONE (1) POLYAXIAL HEAD HOLDER FOR USS POLYAXIAL. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12370014 ↗
• MalfunctionApr 21, 2021Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT THE USS POLYAX SCRHOLDER WAS SNAPPED AND IT¿S BECAME USELESS FOR FUTURE DEMOS. IT WAS HAPPENED IN AN INHOUSE TRAINING SESSION. THERE WERE NO PROCEDURE AND PATIENT INVOLVEMENT WAS REPORTED. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) POLYAXIAL HEAD HOLDER FOR USS POLYAXIAL. THIS REPORT IS 1 OF 1 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11703600 ↗
• MalfunctionApr 9, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2021, THREE (3) POLYAXIAL HEAD HOLDERS BROKE. SPARE INSTRUMENTS WERE AVAILABLE TO COMPLETE THE PROCEDURE. THERE WAS A FIVE (5) MINUTES SURGICAL DELAY. THERE WAS NO PATIENT IMPACT. SURGERY COMPLETED SUCCESSFULLY. THIS REPORT IS FOR ONE (1) POLYAXIAL HEAD HOLDER FOR USS POLYAXIAL. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11645857 ↗
• MalfunctionApr 9, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2021, THREE (3) POLYAXIAL HEAD HOLDERS BROKE. SPARE INSTRUMENTS WERE AVAILABLE TO COMPLETE THE PROCEDURE. THERE WAS A FIVE (5) MINUTES SURGICAL DELAY. THERE WAS NO PATIENT IMPACT. SURGERY COMPLETED SUCCESSFULLY. THIS REPORT IS FOR ONE (1) POLYAXIAL HEAD HOLDER FOR USS POLYAXIAL THIS IS REPORT 2 OF 3 FOR COMPLAINT PC (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11645854 ↗
• MalfunctionApr 9, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6), 2021, THREE (3) POLYAXIAL HEAD HOLDER BROKE. SPARE INSTRUMENTS WERE AVAILABLE TO COMPLETE THE PROCEDURE. THERE WAS A FIVE (5) MINUTES SURGICAL DELAY. THERE WAS NO PATIENT IMPACT. SURGERY COMPLETED SUCCESSFULLY. THIS REPORT IS FOR ONE (1) POLYAXIAL HEAD HOLDER FOR USS POLYAXIAL THIS IS REPORT 1 OF 3 FOR COMPLAINT PC (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11645841 ↗
• MalfunctionMar 24, 2021Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE TOP OF THE USS II POLYAXIAL DRIVER BROKE OFF. THERE WAS NO SURGERY DELAY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH ANOTHER AVAILABLE INSTRUMENT. THERE WAS NO ADVERSE PATIENT HARM. THIS REPORT INVOLVES ONE (1) POLYAXIAL HEAD HOLDER FOR USS POLYAXIAL. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11562913 ↗
• MalfunctionMay 14, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT REVISION SURGERY DUE TO DISENGAGEMENT OF THE TWO (2) UNKNOWN SCREW HEADS ON THE TOP RIGHT AND ONE (1) UNKNOWN SCREW HEAD ON THE TOP LEFT OF THE CONSTRUCT FROM AN UNKNOWN SCREW SHAFTS. INITIALLY, THE PATIENT WAS REVISED TO AN EXISTING UNIVERSAL SPINE SYSTEMS (USS) POLY CONSTRUCT (3 LEVEL) WAS PROLONGED (2 LEVEL) TO ACHIEVE SPINAL FUSION ON (B)(6) 2019. DURING REVISION, THREE (3) THE USS II POLYAXIAL SCREW HOLDERS BROKE OFF. THEY BROKE LIKE A SPIRAL FRACTURE ON THEIR SHAFT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A 120-MINUTES SURGICAL DELAY REPORTED. PATIENT STATUS IS UNKNOWN. THIS (B)(4) CAPTURES THE INTRA-OPERATIVE EVENT DURING REVISION SURGERY ON (B)(6) 2019 WHICH INVOLVED THE THREE (3) USS II POLYAXIAL SCREW HOLDER BROKE OFF DURING THE PROCEDURE WHILE RELATED COMPLAINT (B)(4) CAPTURES THE POSTOPERATIVE EVENTS THAT INVOLVED DISENGAGEMENT OF THE SCREW HEADS ON THE TOP RIGHT AND SCREW HEAD ON THE TOP LEFT OF THE CONSTRUCT FROM AN UNKNOWN SCREW SHAFTS; (B)(4) CAPTURES THE INTRAOPERATIVE EVENT DURING REVISION ON (B)(6) 2019 THAT INVOLVED THREE DEVICES THA

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8608512 ↗
• MalfunctionMay 14, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT REVISION SURGERY DUE TO DISENGAGEMENT OF THE TWO (2) UNKNOWN SCREW HEADS ON THE TOP RIGHT AND ONE (1) UNKNOWN SCREW HEAD ON THE TOP LEFT OF THE CONSTRUCT FROM AN UNKNOWN SCREW SHAFTS. INITIALLY, THE PATIENT WAS REVISED TO AN EXISTING UNIVERSAL SPINE SYSTEMS (USS) POLY CONSTRUCT (3 LEVEL) WAS PROLONGED (2 LEVEL) TO ACHIEVE SPINAL FUSION ON (B)(6) 2019. DURING REVISION, THREE (3) THE USS II POLYAXIAL SCREW HOLDERS BROKE OFF. THEY BROKE LIKE A SPIRAL FRACTURE ON THEIR SHAFT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A 120-MINUTES SURGICAL DELAY REPORTED. PATIENT STATUS IS UNKNOWN. THIS (B)(4) CAPTURES THE INTRA-OPERATIVE EVENT DURING REVISION SURGERY ON (B)(6) 2019 WHICH INVOLVED THE THREE (3) USS II POLYAXIAL SCREW HOLDER BROKE OFF DURING THE PROCEDURE WHILE RELATED COMPLAINT (B)(4) CAPTURES THE POSTOPERATIVE EVENTS THAT INVOLVED DISENGAGEMENT OF THE SCREW HEADS ON THE TOP RIGHT AND SCREW HEAD ON THE TOP LEFT OF THE CONSTRUCT FROM AN UNKNOWN SCREW SHAFTS; (B)(4) CAPTURES THE INTRAOPERATIVE EVENT DURING REVISION ON (B)(6) 2019 THAT INVOLVED THREE DEVICES THA

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8608472 ↗
• MalfunctionMay 14, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT REVISION SURGERY DUE TO DISENGAGEMENT OF THE TWO (2) UNKNOWN SCREW HEADS ON THE TOP RIGHT AND ONE (1) UNKNOWN SCREW HEAD ON THE TOP LEFT OF THE CONSTRUCT FROM AN UNKNOWN SCREW SHAFTS. INITIALLY, THE PATIENT WAS REVISED TO AN EXISTING UNIVERSAL SPINE SYSTEMS (USS) POLY CONSTRUCT (3 LEVEL) WAS PROLONGED (2 LEVEL) TO ACHIEVE SPINAL FUSION ON (B)(6) 2019. DURING REVISION, THREE (3) THE USS II POLYAXIAL SCREW HOLDERS BROKE OFF. THEY BROKE LIKE A SPIRAL FRACTURE ON THEIR SHAFT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A 120-MINUTES SURGICAL DELAY REPORTED. PATIENT STATUS IS UNKNOWN. THIS (B)(4) CAPTURES THE INTRA-OPERATIVE EVENT DURING REVISION SURGERY ON (B)(6) 2019 WHICH INVOLVED THE THREE (3) USS II POLYAXIAL SCREW HOLDER BROKE OFF DURING THE PROCEDURE WHILE RELATED COMPLAINT (B)(4) CAPTURES THE POSTOPERATIVE EVENTS THAT INVOLVED DISENGAGEMENT OF THE SCREW HEADS ON THE TOP RIGHT AND SCREW HEAD ON THE TOP LEFT OF THE CONSTRUCT FROM AN UNKNOWN SCREW SHAFTS; (B)(4) CAPTURES THE INTRAOPERATIVE EVENT DURING REVISION ON (B)(6) 2019 THAT INVOLVED THREE DEVICES THA

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8608446 ↗
• MalfunctionAug 17, 2018Break; Break

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2018, PATIENT UNDERWENT THE ADOLESCENT IDIOPATHIC SCOLIOSIS SURGERY AT TH5. DURING THE SURGERY, THE COUNTER DID NOT FIT THE SCREW HEAD AND THE SURGEON USED THE SCREW HOLDER TO HOLD THE SCREW HEAD TO GUIDE INSERTING THE COUNTER. AFTER FASTENING THE SCREW, IT WAS REPORTED THAT THE SCREWDRIVER TIP WAS BROKEN WHEN THE SURGEON TRIED TO REMOVE THE DRIVER FROM THE HOLDER. THE BROKEN TIP REMAINED ON THE TOP OF THE SCREW HOLDER AND COULD NOT BE REMOVED. FINALLY, THE SURGEON ATTACHED ANOTHER CHUCK AT THE TOP OF THE HOLDER, SO THAT THE SURGEON COULD REMOVE THE BROKEN FRAGMENT FROM THE HOLDER. THERE WERE NO BROKEN PARTS IN THE PATIENT¿S BODY. THERE WAS LESS THAN THIRTY MINUTES SURGICAL DELAY AND THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR ONE (1) POLYAXIAL HEAD HOLDER FOR USS POLYAXIAL. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7794235 ↗
• MalfunctionAug 16, 2017Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2017, SURGERY FOR THORACIC VERTEBRAE DISLOCATION FRACTURE WAS PERFORMED USING THE USS II POLYAXIAL SYSTEM. THE FIXED AREA WAS T1-T9. DURING THE SURGERY, AT A TIME OF FINAL TIGHTENING, USS-II POLYAX SCREW HOLDER GOT CRACKED. NO BROKEN PARTS ARE FOUND LEFT IN THE BODY. THE SURGERY WAS SUCCESSFULLY COMPLETED WITHOUT ANY DELAY, AND THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. NO FRAGMENTS WERE GENERATED. THIS COMPLAINT INVOLVES 1 PART. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6799338 ↗
• MalfunctionDec 21, 2016Break; Break

  IT WAS REPORTED THAT THE POLYAXIAL SCREWHOLDER BROKE OFF. DISASSEMBLING OF REMOBILIZATION TOOL IS NOT POSSIBLE. FRAGMENTS WERE GENERATED, BUT IT'S UNKNOWN WHETHER ADDITIONAL INTERVENTION WAS NECESSARY. IT IS UNKNOWN WHERE OR WHEN THIS EVENT HAPPENED, BUT THERE WAS NO PATIENT INVOLVED. THIS COMPLAINT INVOLVES ONE PARTS. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6197173 ↗
• MalfunctionDec 21, 2016Break; Break

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS IT WAS REPORTED THAT DURING A POSTERIOR SPINE FUSION OF LEVELS T6-L2 ON (B)(6) 2016, THE OUTER SHEATH OF THE UNIVERSAL SPINAL SYSTEM (USS II) POLYAXIAL HEAD HOLDER SNAPPED WHILE LOCKING THE NUT. THE BROKEN SECTION WAS RETRIEVED. IT WAS NOTED THE SURGEON STATED THE NUT WAS LOCKED SATISFACTORILY, AND THERE WERE ADDITIONAL HEAD HOLDERS AS BACK -UP IN THE SET. THERE WAS NO REPORTED SURGICAL DELAY. NO PATIENT HARM WAS REPORTED. PATIENT STATUS IS UNKNOWN CONCOMITANT PART REPORTED: NUT (QUANTITY 1). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6195349 ↗