UNIPLATE 289706000Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10705034224770), received between Dec 13, 2018 and Feb 2, 2024 — 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• MalfunctionFeb 2, 2024Break; Break

  DEVICE REPORT FROM THE UNITED KINGDOM REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2024, THE TIP OF THE CAM LOCK FINAL TIGHTENER SNAPPED OF IN THE CAM LOCK OF THE PLATE; THE FRAGMENT WAS REMOVED. AN ALTERNATIVE DEVICE WAS AVAILABLE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A UNIPL CAM TGHTNR SHFT TRI-LOBE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18636033 ↗
• MalfunctionAug 19, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM THE UNITED KINGDOM REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING TRAINING ON JULY 21, 2022, THE TORQUE SCREW DRIVER WAS NOT CLICKING. THERE WAS NO PATIENT OR PROCEDURE IMPACT. THIS REPORT IS FOR A UNIPL CAM TGHTNR SHFT TRI-LOBE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15258957 ↗
• MalfunctionApr 1, 2022Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2022, TWO (2) UNIPLATE CAM TIGHTENER SHAFTS WERE FOUND TO BE WORN AND UNUSABLE. THERE WAS REPORTED NO DELAY TO A PROCEDURE. THIS REPORT IS FOR AN UNIPLATE CAM TIGHTENER SHAFT. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13978465 ↗
• MalfunctionApr 1, 2022Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2022, TWO UNIPLATE CAM TIGHTENER SHAFTS WERE FOUND TO BE WORN AND UNUSABLE. THERE WAS REPORTED NO DELAY TO A PROCEDURE. THIS REPORT IS FOR AN UNIPLATE CAM TIGHTENER SHAFT. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13978410 ↗
• MalfunctionMar 3, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, DURING AN UNKNOWN PROCEDURE, THE HEAD OF THE SHAFT WAS BROKEN. NO PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR ONE (1) UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM CAM TIGHTENER SHAFT THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13659894 ↗
• MalfunctionJul 30, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING AN UNKNOWN PROCEDURE THE SURGEON WAS USING THE FINAL TIGHT DRIVER FOR THE UNIPLATE SYSTEM AND THE TIP BROKE OFF. NO HARM TO PATIENT AND THE FRAGMENT WAS REMOVED. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM CAM TIGHTENER SHAFT THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12252417 ↗
• MalfunctionJun 9, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING THE FINAL TIGHTENING THE TIP OFF THE DRIVER STRIPPED OFF AND WAS REMOVED EASILY. OTHER INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS TWO (2) MINUTES SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO FURTHER ISSUES. THERE WAS NO PATIENT CONSEQUENCES REPORTED. THIS REPORT IS FOR ONE (1) UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM CAM TIGHTENER SHAFT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11968775 ↗
• MalfunctionJun 7, 2021Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, TWO (2) UNIPLATE CAM TIGHTENER SHAFTS WERE STRIPPED AND UNABLE TO TURN THE CAM FOR FINAL ASSEMBLY. THE PROCEDURE WAS COMPLETED USING ANOTHER SCREWDRIVER. THERE WAS NO SURGICAL DELAY. THERE IS NO FURTHER INFORMATION AVAILABLE. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) UNIPL CAM TGHTNR SHFT TRI-LOBE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11952941 ↗
• MalfunctionJun 7, 2021Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, TWO (2) UNIPLATE CAM TIGHTENER SHAFTS WERE STRIPPED AND UNABLE TO TURN THE CAM FOR FINAL ASSEMBLY. THE PROCEDURE WAS COMPLETED USING ANOTHER SCREWDRIVER. THERE WAS NO SURGICAL DELAY. THERE IS NO FURTHER INFORMATION AVAILABLE. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) UNIPL CAM TGHTNR SHFT TRI-LOBE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11952925 ↗
• MalfunctionJul 1, 2020Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, UPON OPENING THE SET TO CHECK IMPLANT STOCK, IT WAS NOTED THE SCREWDRIVER END WAS WORN AWAY. THERE WAS NO PROCEDURE AND PATIENT ARE INVOLVED. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) UNIPL CAM TIGHTENER SHAFT TRI-LOBE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10218607 ↗
• MalfunctionMar 24, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE PROCEDURE WAS AN ACDF, AND UNIPLATE WAS USED. THE TORQUE HANDLE IS DAMAGED AND CAUSED THE TORQUE TO SNAP WHILE CARRYING OUT THE FINAL TIGHTENING. THE PROCEDURE WAS DELAYED BY 5-10 MINUTES AS WE HAD TO SOURCE ANOTHER KIT AND USE THE HANDLE AND SHAFT FROM THERE. DIDN¿T AFFECT THE PATIENT OUTCOMES THOUGH AND THE PATIENT WASN¿T HARMED IN THE PROCESS. THIS WAS ALSO NOT A CLINICAL TRIAL. THE SURGEON WENT TO FINAL TIGHTEN THE CAM LOC ON THE PLATE AND HE TORQUE HANDLE NORMALLY CLICKS TO LET HIM KNOW HE¿S TURNED IT ENOUGH - THIS FAILED TO HAPPEN CAUSING THE SHAFT TO SNAP INTO THE LOCK. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWS (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY: 1). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM. THIS REPORT IS 2 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9873312 ↗
• MalfunctionMar 9, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE SURGEON INSERTED THE TORQUE DRIVER INTO THE INDICATED POSITION ON THE PLATE, THEN WHEN TURNING THE TORQUE, THE TOP SNAPPED OFF IN THE CAMLOC. THE SURGEON WAS ABLE TO SUCTION THE TIP OUT SO IT WAS NOT LEFT IN THE IMPLANT. THIS OCCURRED THREE (3) TIMES DURING THE PROCEDURE. ANOTHER DRIVER ON THE SET WAS USED, AND THREE (3) TIPS SNAPPED OFF INTO THE PLATE. ALL FRAGMENTS WERE REMOVED AND DISCARDED. THE SURGEON USED THE OTHER SIDE OF THE DRIVER TO FINALLY TIGHTEN. NO FURTHER INFORMATION PROVIDED. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN); UNKNOWN SCREWDRIVER HANDLE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1); UNKNOWN PLATE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1); HANDLE (PART# 289707000, LOT# E0905, QUANTITY 1). THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9806202 ↗
• MalfunctionMar 9, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE SURGEON INSERTED THE TORQUE DRIVER INTO THE INDICATED POSITION ON THE PLATE, THEN WHEN TURNING THE TORQUE, THE TOP SNAPPED OFF IN THE CAMLOC. THE SURGEON WAS ABLE TO SUCTION THE TIP OUT SO IT WAS NOT LEFT IN THE IMPLANT. THIS OCCURRED THREE (3) TIMES DURING THE PROCEDURE. ANOTHER DRIVER ON THE SET WAS USED, AND THREE (3) TIPS SNAPPED OFF INTO THE PLATE. ALL FRAGMENTS WERE REMOVED AND DISCARDED. THE SURGEON USED THE OTHER SIDE OF THE DRIVER TO FINALLY TIGHTEN. NO FURTHER INFORMATION PROVIDED. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN); UNKNOWN SCREWDRIVER HANDLE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1); UNKNOWN PLATE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1); HANDLE (PART# 289707000, LOT# E0905, QUANTITY 1). THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9806201 ↗
• MalfunctionSep 12, 2019Break; Break

  C6/C7 ACDF: DR (B)(6), (B)(6) 2019. THE SURGEON ATTEMPTED TO TIGHTEN THE CAM LOCK WITH THE CAM TIGHTENER AND THE TIP OF THE INSTRUMENT SHEARED OFF. HE RETRIEVED THE BROKEN SECTION OF THE INSTRUMENT WITH FORCEPS. THE SCRUB CHANGED THE CAM TIGHTENER TO THE OTHER SIDE AND THE SURGEON TRIED AGAIN. THE OTHER SIDE OF THE INSTRUMENT SHEARED OFF. THE BROKEN TIP WAS RETRIEVED. THE SCRUB CHANGED THE INSTRUMENT TO THE OTHER CAM TIGHTENER ON THE SET AND THE SURGEON ATTEMPTED TO TIGHTEN THE CAM LOCKS AGAIN. BOTH CAM LOCKS WERE TIGHTENED AND THE SURGEON SAID HE WAS SATISFIED WITH THE FINAL RESULT. PLEASE SEE THE ATTACHED PHOTOS. NO AE REPORTED. FEW MINUTES DELAY TO THE SURGERY. EQ NO. (B)(4). CONCOMITANT DEVICE REPORTED: UNKNOWN SCREW (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY: UNKNOWN). THIS COMPLAINT INVOLVES ONE (1) DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9007129 ↗
• MalfunctionJul 29, 2019Break; Break

  TO WHOM IT MAY CONCERN: DATE J&J BECAME AWARE: 05/07/19. DATE OF EVENT: (B)(6) 2019, 4.30 PM. (B)(6). PRODUCT: UNIPLATE TORQUE DRIVER. LOT/BATCH/EXP: GM3504102. PRODUCT NUMBER: 28970600. DID THE EVENT HAPPEN DURING A PROCEDURE? YES. WERE YOU IN THE PROCEDURE AT THE TIME OF THE EVENT? YES. WAS THE PRODUCT BEING USED IN A CLINICAL TRIAL? NO. EVENT OUTCOME/HOW WAS IT MANAGED? SURGEON TURNED THE DRIVER ROUND AS IT¿S DOUBLE ENDED. WAS THERE A PATIENT IMPACT OR WAS THE PROCEDURE DUE TO THE FAILURE? NO. HAS THE REPORTER FACILITY INDICATED THERE MAY BE LEGAL ACTION? NO. IS THE PRODUCT AVAILABLE FOR RETURN? YES ONCE CLEANED . PLEASE GIVE A DETAILED EXPLANATION OF THE EVENT: SURGEON INSERTER THE TORQUE DRIVER INTO THE INDICATED POSITION ON THE PLATE WHEN TO TURN THE TORQUE AND THE TOP SNAPPED OFF IN THE CAMLOC. THE SURGEON WAS ABLE TO SUCTION THE TIP OUT SO IT WAS NOT LEFT IN THE IMPLANT AND POSSIBLY MIGRATE IN THE PATIENT. THE SURGEON USED THE OTHER SIDE OF THE DRIVER TO FINAL TIGHTEN AS IT IS DOUBLE ENDED. THIS COMPLAINT INVOLVES ONE (1) DEVICE.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8837793 ↗
• MalfunctionDec 13, 2018Break; Break

  IT WAS REPORTED THAT C5/6 ACDF; DR. (B)(6), (B)(6) HOSPITAL, (B)(6) 2018. DURING FINAL TIGHTENING OF THE CAM LOCK ON THE UNI-PLATE, THE DISTAL TIP OF THE FINAL TIGHTENER SHEARED OFF. THE DISTAL TIP WAS THEN RETRIEVED WITH A SUCKER AND NO ADVERSE EVENT OCCURRED. THE REP ASKED ON TWO OCCASIONS IF THE DISTAL TIP HAD BEEN RETRIEVED AND THIS WAS CONFIRMED BY THE SURGEON. SURGEON ADVISED THAT IT WAS SUCKED UP AND NO LONGER IN THE PATIENT. ACTION TAKEN TO MANAGE THE PROBLEM: JNJ REPRESENTATIVE SUGGESTED TO SURGEON TO USE SUCKER TO REMOVE THE DISTAL TIP OF DRIVER. ANOTHER DRIVER WAS USED TO LOCK OFF/TORQUE OFF. NO AE TO PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8161047 ↗