Zero-P 04.617.128SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705034741918), received between Sep 10, 2018 and Mar 6, 2026 — classified as 1 injury, 3 malfunctions.

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

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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 6, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT ON (B)(6) 2026 WHEN TRYING TO INSERT SCREWS INTO THE ZERO-P SPACER, THE PLATE COMPLETELY DETACHED FROM THE CAGE. NO SURGERY DELAYED DUE TO THE REPORTED EVENT. HAD TO TAKE OUT THE CAGE AND REPLACE IT. PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24536168 ↗
• MalfunctionSep 29, 2021Mechanical Problem; Mechanical Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 THE DURING THE COLUMN ARTHRODESIS SURGERY, MATERIAL CONSIGNED CAGE FOR COLUMN FUSION REPORTED BY THE DOCTOR WAS LOOSE AND IMPOSSIBLE TO USE. IT WAS THEN DELIVERED TO CME FOR DISINFECTION TO DELIVER IT TO THE COMPANY. THIS COMPLAINT WAS RECEIVED DIRECTLY FROM BRAZILIAN HEALTH AUTHORITY (ANVISA), THEREFORE NO FURTHER INFORMATION CAN BE OBTAINED OTHER THAN WHAT IS DESCRIBED. THIS REPORT IS FOR ONE (1) ZERO-P IMPLANT 8MM HEIGHT LORDOTIC-STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12549146 ↗
• MalfunctionApr 8, 2019Break; Break

  CONCOMITANT DEVICE REPORTED: UNKNOWN ANGLED AWL (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1), PEEK 8 (PART # PEEK 8, LOT # 9732401, QUANTITY # 1).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8492012 ↗
• InjurySep 10, 2018Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  CONCOMITANT DEVICE: 3.0MM TITANIUM (TI) CERVICAL LOCKING SCREW 14MM (PART: 04.617.814, LOT: UNKNOWN. QUANTITY: 3).

  Patient problems: Foreign Body In Patient; No Code Available

  MAUDE report 7859858 ↗

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.