Symmetry Classic Plus® Mayo-Hegar 36-2018Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00887482009727), received between Aug 24, 2018 and Sep 20, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (3 reports).

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

• MalfunctionSep 20, 2023Material Fragmentation; Material Fragmentation

  THE CUSTOMER ALLEGED THAT DURING A DECOMPRESSION POSTERIOR LUMBAR WITH FUSION EXTENSION TO L1 AND ANTERIOR LUMBAR INTERBODY FUSION WITH VASCULAR ASSIST, ONE SIDE OF THE JAWS BROKE OFF ENTIRELY. THE PIECE FELL INTO THE PATIENT AND WAS RETRIEVED WITH NO FURTHER HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17785551 ↗
• MalfunctionSep 20, 2023Material Fragmentation; Material Fragmentation

  THE CUSTOMER ALLEGED THAT DURING A DECOMPRESSION POSTERIOR LUMBAR WITH FUSION EXTENSION TO L1 AND ANTERIOR LUMBAR INTERBODY FUSION WITH VASCULAR ASSIST, HALF OF A JAW INSERT BROKE AWAY FROM THE JAW. THE PIECE FELL INTO THE PATIENT AND WAS RETRIEVED WITH NO FURTHER HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17785549 ↗
• MalfunctionAug 29, 2023

  DURING THE PROCEDURE, TWO NEEDLE HOLDERS MALFUNCTIONED. THE ONE DRIVER HAD A PIECE COMPLETELY MISSING, AND THE OTHER NEEDLE DRIVER HAD ABOUT HALF OF THE HEAD FLAKED OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17641262 ↗
• MalfunctionAug 24, 2018Break; Material Fragmentation

  A NEEDLE HOLDER INSERT BROKE DURING A SURGICAL PROCEDURE INTO SEVERAL PIECES. THE BREAKAGE WAS NOT NOTICED UNTIL THE INSTRUMENT MADE IT TO CENTRAL PROCESSING. AN X-RAY WAS CONDUCTED ON THE PATIENT AND DETERMINED THAT PIECES OF THE INSERT WERE LEFT IN THE PATIENT. THE FACILITY DETERMINED THEY DID NOT NEED TO RE-OPEN THE PATIENT TO RETRIEVE THE PIECES AT THIS TIME. THE NEEDLE HOLDER HAD BEEN REPAIRED BY A THIRD-PARTY REPAIR FACILITY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7815150 ↗