NA 03.647.901Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705034720739), received between Aug 23, 2019 and Aug 24, 2026 — classified as 4 malfunctions.

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

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 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.

• MalfunctionAug 24, 2026Mechanical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50417732 ↗
• MalfunctionOct 14, 2024Use of Device Problem; Use of Device Problem

  THIS INSTRUMENT IS COMPOSED OF 4 PARTS. THE INSTRUMENT IS MISSING A SPRING AND ANOTHER PART. THIS WAS IDENTIFIED DURING LOAN KIT INSPECTION BY THE LOAN KIT TECHNICIAN. THE EVENT DATE AND ALERT DATE ARE THE DATE THAT THE INSPECTION TOOK PLACE. THERE ARE NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20439634 ↗
• MalfunctionAug 12, 2020Device-Device Incompatibility; Device-Device Incompatibility

  THE EVENT WAS INTRA OPERATIVE. THE PATIENT WAS FINE AND THE CASE CONTINUED AS NORMAL. BONE WAX HAD TO BE USED ON THE SCREWDRIVER TO RETAIN THE SCREW WHICH MAY HAVE CAUSED A SLIGHT SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10396862 ↗
• MalfunctionAug 23, 2019Break; Break

  IT WAS REPORTED THAT DURING A ROUTINE INCOMING INSPECTION OF A LOANER SET AT A FIELD STOCKING LOCATION (FSL) ON AN UNKNOWN DATE, IT WAS OBSERVED THAT A HOLDING SLEEVE FOR STARDRIVE SCREWDRIVER WAS BROKEN. THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS REPORT IS FOR A HOLDING SLEEVE FOR STARDRIVE SCREWDRIVER SHAFT T8. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8927006 ↗

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