NA 04.647.878Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10705034751443), received between Apr 2, 2018 and Sep 13, 2024 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (3 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.

• InjurySep 13, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON (B)(6) 2024 THE SCREW BACKED OUT OF ZERO PVA CERVICAL IMPLANT FROM A CASE THAT WAS DONE A YEAR AGO. ON (B)(6) 2024, THE PATIENT UNDERWENT A REVISION SURGERY TO REMOVE THE SCREW THAT WAS BACKING OUT. NO FURTHER INFORMATION IS PROVIDED. THIS REPORT IS FOR ONE (1) 3.7MM TI CERVICAL SPINE SCREW SLF-TPNG/VARIABLE ANGLE 18MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 20217704 ↗
• MalfunctionMar 14, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, THE ZERO-P LORDOTIC IMPLANT AND SCREWS IN QUESTION THAT WERE ORIGINALLY IMPLANTED IN C2-3 ACDF HAD TO BE REMOVED DUE TO THE SCREWDRIVER SHAFT AND SCREW HEADS STRIPPING DURING INSERTING. THEY WERE REPLACED WITH A MTF FREEZE DRIED ALLOGRAFT SPACER AND PLATE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A 30 MINUTE SURGICAL DELAY AND THE EXTENDED USE OF FLUOROSCOPY. THE PATIENT OUTCOME WAS STABLE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 3.7MM TI CERVICAL SPINE SCREW SLF-TPNG/VARIABLE ANGLE 18MM. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18904013 ↗
• MalfunctionMar 14, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON 22-FEBRUARY-2024, THE ZERO-P LORDOTIC IMPLANT AND SCREWS IN QUESTION THAT WERE ORIGINALLY IMPLANTED IN C2-3 ACDF HAD TO BE REMOVED DUE TO THE SCREWDRIVER SHAFT AND SCREW HEADS STRIPPING DURING INSERTING. THEY WERE REPLACED WITH A MTF FREEZE DRIED ALLOGRAFT SPACER AND PLATE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A 30 MINUTE SURGICAL DELAY AND THE EXTENDED USE OF FLUOROSCOPY. THE PATIENT OUTCOME WAS STABLE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 3.7MM TI CERVICAL SPINE SCREW SLF-TPNG/VARIABLE ANGLE 18MM. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18904009 ↗
• MalfunctionMar 14, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, THE ZERO-P LORDOTIC IMPLANT AND SCREWS IN QUESTION THAT WERE ORIGINALLY IMPLANTED IN C2-3 ACDF HAD TO BE REMOVED DUE TO THE SCREWDRIVER SHAFT AND SCREW HEADS STRIPPING DURING INSERTING. THEY WERE REPLACED WITH A MTF FREEZE DRIED ALLOGRAFT SPACER AND PLATE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A 30 MINUTE SURGICAL DELAY AND THE EXTENDED USE OF FLUOROSCOPY. THE PATIENT OUTCOME WAS STABLE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 3.7MM TI CERVICAL SPINE SCREW SLF-TPNG/VARIABLE ANGLE 18MM. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18904004 ↗
• InjuryDec 31, 2018Difficult to Advance; Material Twisted/Bent; Difficult to Advance; Material Twisted/Bent

  CONCOMITANT DEVICE/S REPORTED: UNKNOWN SCREWDRIVER (PART # UNKNOWN, LOT UNKNOWN, QUANTITY 1).

  Patient problems: No Code Available

  MAUDE report 8206028 ↗
• InjuryApr 2, 2018Dull, Blunt; Dull, Blunt

  IT WAS REPORTED THAT DURING REVISION PROCEDURE ON (B)(6) 2018, 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 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. 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 REPORT ADDRESSES THE INTRAOPERATIVE EVENT OF ZERO-P VA 18MM SCREW WOULD NOT MOVE PAST 16MM OF DEPTH, SPUN IN PLACE AND WOU

  Patient problems: No Code Available

  MAUDE report 7390772 ↗

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