Zero-P 04.617.136SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034741970), received between Jun 21, 2019 and Jun 21, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 21, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, A ZERO-P CONVEX IMPLANT WAS DISASSEMBLED/DISCONNECTED AT THE TIME OF PLACING IT DURING AN UNKNOWN PROCEDURE. THERE WAS NO SURGICAL DELAY REPORTED. PROCEDURE OUTCOME WAS UNKNOWN. THERE WAS NO PATIENT CONSEQUENCE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8722412 ↗

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.