Zero-P 04.617.127SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034741901), received between Feb 26, 2018 and Jul 26, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K072981); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 26, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A C4-C6 ANTERIOR CERVICAL FUSION ON (B)(6) 2018. DURING SURGERY, ONE (1) ZERO-P IMPLANT WAS SUCCESSFULLY PLACED IN THE C5-C6 SPACE. THE SURGEON THEN MOVED TO THE C4-C5 SPACE. THE SURGEON THEN PLACED THE DISTRACTOR PINS AT C4 AND C5 AND THEN PUT THE CERVICAL DISTRACTOR ON THE PINS AND PLACED DISTRACTION ON THE C4-C5 DISC SPACE. THE SURGEON THEN COMPLETED THE DISCECTOMY AND THEN DECIDED TO USE ONE (1) ZERO-P LORDOTIC IMPLANT. THE SURGEON PLACED THE IMPLANT ON THE AIMING DEVICE AND TRIED TO IMPACT THE IMPLANT IN C4-C5 SPACE. THE C4 DISTRACTION PIN AND DISTRACTOR WAS CLOSE TO THE C4-C5 DISC SPACE AND IMPEDED THE PLACEMENT OF THE ZERO-P DEVICE. WHILE TRYING TO PLACE THE DEVICE, THE ZERO-P SPACER CAME APART FROM THE IMPLANT. THE SURGEON WAS NOT COMFORTABLE WITH PUTTING THE IMPLANT BACK TOGETHER AND ASKED TO HAVE A NEW IMPLANT OF SAME SIZE AND TYPE. THE SURGEON THEN REMOVED THE DISTRACTOR AND DISTRACTION PINS. THE SURGEON THEN PLACED THE NEW ZERO-P IMPLANT SUCCESSFULLY. THE SURGEON THEN PLACED ALL THE SCREWS IN. THE SURGEON BELIEVED THAT THE DISTRACTION PIN LEVERED THE PLATE AWAY FROM THE SPACER DURING IMPLANTATION CAUSING IT TO SEPARATE. THE SUR

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7722053 ↗
• MalfunctionFeb 26, 2018Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A SPINAL FUSION PROCEDURE PERFORMED ON (B)(6) 2018, A ZERO-P IMPLANT 7MM HEIGHT SPLIT APART PRIOR TO FINAL IMPLANTATION IN THE PATIENT. THE IMPLANT WAS THEREFORE REMOVED FROM USE AND ANOTHER READILY AVAILABLE IMPLANT WAS USED INSTEAD. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7296270 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K072981. One submission often covers many models, so check the product and lot details in each record.

• Z-0104-2012 · Sep 23, 2011 · Terminated
  Synthes Spine Zero-P Instruments and Implants. Zero-profile anterior cervical interbody fusion (ACIF) device.
• Z-1348-2009 · Feb 10, 2009 · Terminated
  Synthes Zero-P StarDrive Screwdriver Shaft, T8, self-retaining, quick coupling, for use in spinal fusion surgery. Catalog # 03.617.902 Technique Guide.