SureMAX-SA 1Recalls & reported problems
Additive Implants, LLC · INNER SHAFT FOR INSERTER AND AWL GUIDES · Class 1 · Implant
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00817662025773), received between May 18, 2022 and May 18, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Use of Device Problem” (1 report).
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
Device problems
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 18, 2022Use of Device Problem; Use of Device Problem
ON A LOW-PROFILE INSERTER TIP, THE THREADED PORTION SHEARED OFF IN THE IMPLANT DURING AGGRESSIVE POSITIONING. THE SURGEON COULD NOT GET THE IMPLANT OUT AS IT WAS WELL FIXED. ADDITIONALLY THE THREADED PORTION REMAINED THREADED INTO THE IMPLANT AND HE COULD NOT REMOVE THAT. HE WAS ABLE TO PLACE A SCREW AND LOCK THE LOCKING MECHANISM WITHOUT DIFFICULTY AND PLACED A PLATE WHICH HE WAS PLANNING ON REPLACING ANYWAY ANTERIORLY AND SUBSEQUENTLY INFORMED THE HOSPITAL AND THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14428848 ↗
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.