NA 04.647.836Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705034751368), received between Apr 2, 2018 and May 17, 2024 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Compatibility Problem” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K112068); they may or may not involve this specific model.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 17, 2024Compatibility Problem; Compatibility Problem

  IT WAS REPORTED THAT ON FEBRUARY 3, 2024, AFTER DRILLING THE SCREW INTO THE SCREW HOLE OF THE CAGE, THE SCREW COULD NOT BE BACKED OUT AGAIN FOR ANGLE CORRECTION BECAUSE THE PLATE ON THE CAGE WAS STUCK. IT WILL NOT UNLOCK. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT WAS IN STABLE CONDITION. THIS REPORT INVOLVES ONE (1) 3.7MM TI CERVICAL SPINE SCREW SLF-DRLG/VARIABLE ANGLE 16MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19339532 ↗
• MalfunctionApr 18, 2022Compatibility Problem; Compatibility Problem

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THIS IS REPORT 2 OF 3 FOR (B)(4). IT WAS REPORTED BY THE SALES REP IN CANADA THAT DURING AN UNKNOWN SURGERY ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE FUSION CAGE DEVICE WAS UNSTABLE IN ITS ROTATION AND COULD NOT BE USED. ACCORDING TO THE REPORT, TWO SCREW DEVICES WERE WASTED AS A RESULT. ANOTHER LIKE DEVICES WERE USED TO COMPLETE THE PROCEDURE WITH A DELAY OF 10 MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) 3.7 TI CERV SPINE SCREW SLF-DRLG/VA 16MM DEVICE. THIS COMPLAINT INVOLVES THREE (3) DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14137471 ↗
• MalfunctionJan 16, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN ANTERIOR CERVICAL FUSION ON (B)(6) 2018, THE SURGEON WAS NOT ABLE TO FULLY SEAT THE TITANIUM CERVICAL SPINE SCREW SELF -DRILLING/VARIABLE ANGLE TO ENGAGE THE LOCKING MECHANISM. AFTER USING SUPPLIED AWL, THE SURGEON ATTEMPTED MULTIPLE TIMES USING THE ANGLED AND STRAIGHT SCREWDRIVER TO FULLY SEAT THE SCREW WITHIN LOCKING ZONE (PAST THE LOCKING BUTTON ON THE PLATE). THE SURGEON TRIED TO USE THE SCREW REMOVAL SCREWDRIVER IN AN ATTEMPT TO GET BETTER PURCHASE WHEN TRYING TO FULLY ENGAGE THE SCREW. SURGEON WAS UNABLE TO DO SO AND FELT CONFIDENT IN LEAVING THE SCREW 1MM PROUD. SURGEON MENTIONED THAT THE SCREW WAS NOT MOVING, AND HE DIDN¿T WANT TO ATTEMPT TO REMOVE THE SCREW BEYOND WHAT HAD BEEN ATTEMPTED. SURGEON DID NOT WANT TO CAUSE MORE HARM IN TRYING TO REMOVE THE SCREW. THE REST OF THE OPERATION CONTINUED, AND SURGEON WAS SATISFIED. THERE WAS AN UNKNOWN SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICES: SCREWDRIVER (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: UNKNOWN), PLATE (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: UNKNOWN). THIS REPORT IS FOR A 3.7MM TITANIUM (TI) CERVICAL SPINE SCREW. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8252644 ↗
• MalfunctionJul 30, 2018Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2018, PATIENT UNDERWENT A CERVICAL 5/6 ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) SURGERY. DURING THE SURGERY WHILE THE SURGEON WAS IMPLANTING SCREWS, A SUPERIOR SCREW WAS LOCKED OFF DUE TO THE STARDRIVE SHAFT BEING STRIPPED AND NOT ABLE TO ENGAGE IN THE HEAD OF THE SCREW. THE BLOCKING SCREW WAS NOT ENGAGED. SCREW WAS NOT LOCKED OFF. THE INFERIOR SCREW WAS LOCKED BUT IT WAS ALSO STRIPPED. THE SURGEON TRIED TO USE THE SAME PRODUCT, STARDRIVE SCREWDRIVER SHAFT BUT IT FAILED. BOTH STARDRIVE SCREWDRIVER SHAFTS WERE NOT FUNCTIONING AND COULD NOT BE USED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS A TEN-MINUTE SURGICAL DELAY. THERE WAS NO ADVERSE EFFECT TO THE PATIENT. THE PATIENT WAS STABLE. THIS REPORT IS FOR ONE (1) 3.7MM TI CERVICAL SPINE SCREW SLF-DRLG/VARIABLE ANGLE 16MM. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7732812 ↗
• MalfunctionJul 30, 2018Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2018, PATIENT UNDERWENT A CERVICAL 5/6 ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) SURGERY. DURING THE SURGERY WHILE THE SURGEON WAS IMPLANTING SCREWS, A SUPERIOR SCREW WAS LOCKED OFF DUE TO THE STARDRIVE SHAFT BEING STRIPPED AND NOT ABLE TO ENGAGE IN THE HEAD OF THE SCREW. THE BLOCKING SCREW WAS NOT ENGAGED. SCREW WAS NOT LOCKED OFF. THE INFERIOR SCREW WAS LOCKED BUT IT WAS ALSO STRIPPED. THE SURGEON TRIED TO USE THE SAME PRODUCT, STARDRIVE SCREWDRIVER SHAFT BUT IT FAILED. BOTH STARDRIVE SCREWDRIVER SHAFTS WERE NOT FUNCTIONING AND COULD NOT BE USED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS A TEN-MINUTE SURGICAL DELAY. THERE WAS NO ADVERSE EFFECT TO THE PATIENT. THE PATIENT WAS STABLE. THIS REPORT IS FOR ONE (1) 3.7MM TI CERVICAL SPINE SCREW SLF-DRLG/VARIABLE ANGLE 16MM. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7732811 ↗
• InjuryApr 2, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A REVISION PROCEDURE ON (B)(6) 2018 DUE TO POOR ANGULATION OF A 16MM ZERO-P VA SCREW AND A HEMATOMA. THE PATIENT WAS INITIALLY IMPLANTED WITH A ZERO-P VA CAGE AND TWO (2) 16MM SCREWS ON (B)(6) 2018 DUE TO DEGENERATIVE DISC DISEASE (DDD) AT C5-C6. DURING A FOLLOW-UP MAGNETIC RESONANCE IMAGING (MRI), THE SURGEON DIDN¿T LIKE THE ANGULATION OF ONE (1) OF THE IMPLANTED 16MM SCREWS AND WANTED A SCREW WITH A BIGGER PURCHASE INTO THE VERTEBRAL BODY. THERE WAS NO ISSUE WITH THE SCREW. THE PATIENT WAS BROUGHT BACK FOR A REVISION TO REMOVE A HEMATOMA AND THEY DECIDED TO REMOVE THE 16MM SCREW AND REPLACE IT WITH A 18MM SCREW. DURING THE REVISION PROCEDURE, WHEN ATTEMPTING TO IMPLANT A ZERO-P VA 18MM SELF-TAPPING ¿RESCUE SCREW¿ IN THE IMPLANTED ZERO-P VA CAGE, THE SCREW WOULD NOT MOVE PAST 16MM OF DEPTH. IT SPUN IN PLACE AND WOULD NOT FULLY SEAT. THE 18MM SCREW WAS REMOVED AND A NEW 16MM SCREW WAS IMPLANTED IN ITS PLACE. NO SURGICAL DELAY AND NO PATIENT CONSEQUENCE. THE ZERO-P VA CAGE REMAINED IMPLANTED ALONG WITH THE ONE (1) 16MM SCREW WHICH WAS NEVER EXPLANTED FROM THE (B)(6) 2018 SURGERY. NO SURGICAL DELAY DURING THE INITIAL SURGERY. THIS COMPLAINT IS LIN

  Patient problems: Hematoma; Not Applicable

  MAUDE report 7391234 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K112068. One submission often covers many models, so check the product and lot details in each record.

• Z-0455-2014 · Sep 30, 2013 · Terminated
  Synthes Zero-P VA Implant 7 MM Height Parallel Sterile The Synthes Zero-P VA Implant 7 MM Height Parallel Sterile is a stand alone anterior cervical interbody fusion device indica