UNIPLATE 289707000Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 10705034224787), received between May 22, 2019 and Feb 19, 2026 — classified as 33 malfunctions.

The most frequently reported specific device problem is “Calibration Problem” (24 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 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 19, 2026Calibration Problem

  IT WAS REPORTED THE HANDLE DID NOT MEET SPECIFICATIONS FOR TORQUE TESTING. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24389026 ↗
• MalfunctionDec 26, 2023Calibration Problem; Calibration Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THE DEVICE WAS FOUND TO BE OUT OF TOLERANCE. NO PATIENT INVOLVEMENT. THIS REPORT IS FOR UNIPLATE CAM TGHTNR TORQ HNDL FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18394194 ↗
• MalfunctionNov 30, 2023Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2023 DURING INCOMING INSPECTION OF A LOANER SET, THE TORQUE HANDLE IN QUESTION WAS FOUND TO BE OUT OF SPECIFICATION. THE TORQUE WAS MEASURING HIGHER THAN INTENDED. THERE WAS NO REPORTED PATIENT OR PROCEDURE INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM CAM TIGHTENER TORQUE HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18239172 ↗
• MalfunctionOct 12, 2023Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, IT WAS IDENTIFIED DURING LOAN KIT INSPECTION THAT THE DEVICE¿S TORQUE WAS TESTING HIGH. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT INVOLVES ONE UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM CAM TIGHTENER TORQUE HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17923787 ↗
• MalfunctionSep 5, 2023Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON (B)(6) 2023 DURING ROUTINE INCOMING INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT THE TORQUE DEVICE WAS FOUND TO BE OUT OF SPECIFICATION. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT IS FOR A UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM CAM TIGHTENER TORQUE HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17682104 ↗
• MalfunctionAug 7, 2023Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, DURING ROUTINE INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT THE UNIPLATE CAM TIGHTENER TORQUE HANDLE WAS FOUND TO BE OUT OF DRAWING SPECIFICATION. THE TORQUE TESTED HIGH. THERE WAS NO KNOWN PATIENT OR PROCEDURE INVOLVEMENT. THIS REPORT INVOLVES ONE UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM CAM TIGHTENER TORQUE HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17468782 ↗
• MalfunctionApr 15, 2022Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING ROUTINE INCOMING INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT THE TORQUE HANDLE WAS FOUND TO BE OUT OF DRAWING SPECIFICATION. THE TORQUE TESTED HIGH. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT IS FOR ONE (1) UNIPLATE CAM TGHTNR TORQ HNDL. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14119631 ↗
• MalfunctionFeb 14, 2022Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING ROUTINE INCOMING INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT THE UNIPLATE CAM TGHTNR TORQ HNDL WAS FOUND TO BE OUT OF SPECIFICATION AND THE TORQUE TESTED HIGH. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT INVOLVES ONE (1) UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM CAM TIGHTENER TORQUE HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13525016 ↗
• MalfunctionFeb 14, 2022Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING ROUTINE INCOMING INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT THE UNIPLATE CAM TGHTNR TORQ HNDL WAS FOUND TO BE OUT OF SPECIFICATION. THE TORQUE TESTED HIGH. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT INVOLVES ONE (1) UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM CAM TIGHTENER TORQUE HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13524963 ↗
• MalfunctionNov 24, 2021Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A ROUTINE INCOMING INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT THE TORQUE HANDLE WAS OUT OF DRAWING SPECIFICATION. THE STANDARD DRAWING SPECIFICATION IS 0.63 - 0.98. THE TORQUE TESTED HIGH AT 1.07. THERE WAS NO KNOWN PATIENT OR PROCEDURE INVOLVEMENT. THIS REPORT IS FOR ONE (1) UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM CAM TIGHTENER TORQUE HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12868514 ↗
• MalfunctionSep 24, 2021Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THE PATIENT UNDERWENT ANTERIOR SPINE SURGERY WITH A SKYLINE PLATE. AFTER TIGHTENING THE CAMLOCK OF THE PLATE, THE CAMLOCK HAD TO BE REOPENED. AS THE LEFT TURN WAS EXECUTED WITH THE TORQUE LIMITING HANDLE AND CAMLOCK SCREWDRIVER, THE HANDLE GAVE WAY AND LATER UNSCREWED ITSELF AND FELL APART. THE UNLOCKING OF THE SCREWS HAD TO BE PERFORMED WITH THE CAMLOCK SCREWDRIVER SHAFT AND A JACOBS CHUCK. THIS REPORT IS FOR A TORQUE LIMITING HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12527163 ↗
• MalfunctionJul 15, 2021Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, IT WAS DISCOVERED THAT THE SKYLINE ITEMS ARE UNABLE TO BE USE IN THE CASE. THERE WERE NO PATIENT CONSEQUENCES. THE TOQUE SEEMED LOOSE, AND DRIVER WOULD NOT RETAIN. PROCEDURE OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) UNIPLATE CAM TGHTNR TORQ HNDL. THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12176531 ↗
• MalfunctionMay 28, 2021Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING ROUTINE INCOMING INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT THE TORQUE HANDLE WAS FOUND TO BE OUT OF DRAWING SPECIFICATION. THE DRAWING SPECIFICATION IS .63-.98. THE TORQUE TESTED HIGH ¿ 1.028. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) UNIPLATE CAM TIGHTENER TORQ HNDL. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11902174 ↗
• MalfunctionFeb 2, 2021Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, CG LABS RECEIVED THE UNIPLATE CAM TIGHTENER TORQUE HANDLE; LOT # E0410 FROM LYNDHURST, NJ 07071 ON 12/10 AS A BLIND UNIT. THE TORQUE FOR THE INSTRUMENT UNIPLATE CAM TGHTNR TORQ HNDL IS MEASURING OVER TORQUE. NO OTHER DETAILS PROVIDED. NO SURGERY DELAY REPORTED, THERE WERE NO PATIENT CONSEQUENCES. PROCEDURE OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) UNIPLATE CAM TIGHTENER TORQ HNDL THIS IS REPORT 1 OF 1 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11268827 ↗
• MalfunctionJun 18, 2020Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING ROUTINE INCOMING INSPECTION OF A LOANER SET, THE TORQUE HANDLE WAS FOUND TO BE OUT OF DRAWING SPECIFICATION. THE DRAWING SPECIFICATION IS .63-.98. THE TORQUE TESTED HIGH ¿ 1.00. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM CAM TIGHTENER TORQUE HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10169365 ↗
• MalfunctionJun 18, 2020Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING ROUTINE INCOMING INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT THE TORQUE HANDLE WAS FOUND TO BE OUT OF DRAWING SPECIFICATION. THE DRAWING SPECIFICATION IS .63-.98. THE TORQUE TESTED LOW ¿ .48. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10168239 ↗
• MalfunctionApr 30, 2020Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING ROUTINE INCOMING INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT THE TORQUE HANDLE WAS FOUND TO BE OUT OF DRAWING SPECIFICATION. THE DRAWING SPECIFICATION IS .63-.98. THE TORQUE TESTED LOW ¿ 0.483. THE PRODUCT HAS BEEN QUARANTINED AND IS AVAILABLE AND IS BEING RETURNED. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10014598 ↗
• MalfunctionMar 24, 2020Calibration Problem; Calibration Problem

  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 1 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9873317 ↗
• MalfunctionMar 11, 2020Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE. DURING A ROUTINE INCOMING INSPECTION OF A LOANER SET, THE TORQUE HANDLE WAS FOUND TO BE OUT OF DRAWING SPECIFICATION. THE DRAWING SPECIFICATION IS .63-.98. THE TORQUE TESTED AT 1.62 WHICH IS ABOVE SPECIFICATION. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT IS FOR ONE (1) UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM CAM TIGHTENER TORQUE HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9817486 ↗
• MalfunctionFeb 12, 2020Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A ROUTINE INCOMING INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT THE TORQUE HANDLE WAS FOUND TO BE OUT OF DRAWING SPECIFICATION. THE TORQUE TESTED HIGH. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9700478 ↗
• MalfunctionJan 14, 2020Calibration Problem; Calibration Problem

  IT WAS REPORTED ON AN UNKNOWN DATE, THE TORQUE HANDLE WAS TESTED AND WAS OUTSIDE OF MAJOR RANGE, IT WAS TESTING AT 101.15 N.M. MAX RANGE IS .98 N.M. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) UNIPLATE CAM TGHTNR TORQ HNDL. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9586392 ↗
• MalfunctionJan 7, 2020Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A ROUTINE INCOMING INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT THE TORQUE HANDLE WAS FOUND TO BE OUT OF DRAWING SPECIFICATION. THE DRAWING SPECIFICATION IS .63-.98. THE TORQUE TESTED HIGH ¿ 1.10. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9558073 ↗
• MalfunctionJan 7, 2020Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A ROUTINE INCOMING INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT THE TORQUE HANDLE WAS FOUND TO BE OUT OF DRAWING SPECIFICATION. THE DRAWING SPECIFICATION IS .63-.98. THE TORQUE TESTED HIGH ¿ 1.38. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9557963 ↗
• MalfunctionDec 2, 2019Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING ROUTINE INCOMING INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT THE TORQUE HANDLE WAS FOUND TO BE OUT OF SPECIFICATION. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) UNIPLATE CAM TGHTNR TORQ HNDL. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9397040 ↗
• MalfunctionNov 19, 2019Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT DURING ROUTINE INCOMING INSPECTION OF A LOANER SET ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE TORQUE HANDLE WAS FOUND TO BE OUT OF DRAWING SPECIFICATION. THERE WAS NO PATIENT INVOLVEMENT. WHEN THE DEVICE WAS RECEIVED FOR INVESTIGATION, A VIPER2 TIGHTENER HANDLE WAS ALSO PRESENT. CONCOMITANT DEVICES: VIPER2 TIGHTENER HANDLE (PART: 286745500, LOT: GB109636, QUANTITY: 1). THIS REPORT IS FOR A CAM TIGHTENER TORQUE HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9341790 ↗