SyntheCel SC.400.019.01SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10887587001364), received between Nov 3, 2021 and Nov 3, 2021 — classified as 1 injury.

5 other recalls cover devices cleared under the same FDA submission (K113071, K131792, K212943); 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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryNov 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT HAD A RETROMASTOID CRANIOTOMY WITH SYNTHECEL IMPLANTED FOR DURA REPAIR. PATIENT HAD A REACTION TO THE SYNTHECEL ONE (1) MONTH POST-OP. PATIENT EXPERIENCED CHEMICAL MENINGITIS. PATIENT ALSO HAD STRYKER DIRECT INJECT CEMENT USED. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) SYNTHECEL DURA REPR 2.5CMX7.5CM(1"X3")-S. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 12745571 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K113071, K131792, K212943. One submission often covers many models, so check the product and lot details in each record.

• Z-1386-2016 · Dec 8, 2015 · Terminated
  SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as
• Z-1384-2016 · Dec 8, 2015 · Terminated
  SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as
• Z-1387-2016 · Dec 8, 2015 · Terminated
  SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as
• Z-1385-2016 · Dec 8, 2015 · Terminated
  SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as
• Z-1383-2016 · Dec 8, 2015 · Terminated
  SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as