MEDPOR 80010Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613252084044), received between Mar 30, 2026 and Mar 30, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K922489); 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2026Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT THE NEEDLES USED TO FIX THE MUSCLES IN PLACE COULD NOT BE INSERTED THROUGH THE DESIGNATED OPENINGS, AS THE OPENINGS WERE TOO NARROW AND THE SUTURE CHANNELS WERE NOT CONTINUOUS. THE SURGEON WAS REQUIRED TO APPLY SIGNIFICANT FORCE TO PENETRATE THE SPECIFIED SUTURE CHANNELS, WHICH RESULTED IN THE NEEDLE DEVIATING LATERALLY DURING THE PROCEDURE AND CAUSING AN INJURY TO THE SURGEON. NO SURGICAL DELAY OR ANY MEDICAL INTERVENTION WERE REPORTED AT INTAKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24728330 ↗
• MalfunctionMar 30, 2026Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT THE NEEDLES USED TO FIX THE MUSCLES IN PLACE COULD NOT BE INSERTED THROUGH THE DESIGNATED OPENINGS, AS THE OPENINGS WERE TOO NARROW AND THE SUTURE CHANNELS WERE NOT CONTINUOUS. THE SURGEON WAS REQUIRED TO APPLY SIGNIFICANT FORCE TO PENETRATE THE SPECIFIED SUTURE CHANNELS, WHICH RESULTED IN THE NEEDLE DEVIATING LATERALLY DURING THE PROCEDURE AND CAUSING AN INJURY TO THE SURGEON. NO SURGICAL DELAY OR ANY MEDICAL INTERVENTION WERE REPORTED AT INTAKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24728275 ↗
• MalfunctionMar 30, 2026Device Difficult to Setup or Prepare

  IT WAS REPORTED THAT THE NEEDLES USED TO FIX THE MUSCLES IN PLACE COULD NOT BE INSERTED THROUGH THE DESIGNATED OPENINGS, AS THE OPENINGS WERE TOO NARROW AND THE SUTURE CHANNELS WERE NOT CONTINUOUS. THE SURGEON WAS REQUIRED TO APPLY SIGNIFICANT FORCE TO PENETRATE THE SPECIFIED SUTURE CHANNELS, WHICH RESULTED IN THE NEEDLE DEVIATING LATERALLY DURING THE PROCEDURE AND CAUSING AN INJURY TO THE SURGEON. NO SURGICAL DELAY OR ANY MEDICAL INTERVENTION WERE REPORTED AT INTAKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24727522 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K922489. One submission often covers many models, so check the product and lot details in each record.

• Z-1090-2015 · Dec 17, 2014 · Terminated
  MEDPOR Surgical Implant Contoured Two Piece Chin 5 mm; Part Number 86001; Lot Numbers A1405048, A1404026 Product Usage: MEDPOR Implants in block, sheet and pre-formed shapes are i