SyntheCel SC.400.056.01SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10887587001388), received between Nov 3, 2021 and Jun 21, 2023 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, DURING POST-OP, THERE WAS A FOREIGN BODY REACTION TO SYNTHECEL. TESTS CAME BACK SAYING THE PATIENT WAS HAVING A FOREIGN BODY REACTION. THE PATIENT EXPERIENCED AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING, OR OOZING. THE PATIENT REQUIRED REVISION SURGERY OR HARDWARE REMOVAL. THE NAME OF THE ORIGINAL IMPLANT IS SYNTHECEL. THE DEVICE WAS EXPLANTED. THE PATIENT HAD TO HAVE A SECOND SURGERY TO REMOVE THE SYNTHECEL. THERE WERE PATIENT CONSEQUENCES. THE PATIENT'S DURA WAS VERY INFLAMED. AFTER SYNTHECEL WAS EXPLANTED, THE PATIENT IS DOING A LOT BETTER. OTHER INFORMATION INCLUDES ALLERGIES, SULFA COMORBIDITIES, HYPERTENSION, SLEEP APNEA, AND OSTEOARTHRITIS. THIS REPORT IS FOR ONE (1) SYNTHECEL DURA REPR 7.5CMX7.5CM(3"X3")-S. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Discomfort; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Inflammation; Pain

  MAUDE report 17171016 ↗
• InjuryNov 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021 THE PATIENT UNDERWENT AN ORBITAL ZYGOMATIC MEDIAL SPHENOID WING CRANIOTOMY FOR MENINGIOMA. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THREE (3) TO FOUR (4) MOTHS POST-OP THE PATIENT HAD A REACTION TO THE SYNTHECEL THAT HAD BEEN IMPLANTED. A REVISION OPERATION WAS PERFORMED TO REMOVE THE SYNTHECEL. RESULTS FROM THE SPECIMEN THAT HAD BEEN SENT TO PATHOLOGY WERE AS FOLLOWS: NO INFECTION, FIBROSIS OF FOREIGN BODY TYPE TISSUE REACTION, HISTIOCYTES. SURGICEL, SURGICEL NU-KNIT, FLOWSEAL, IRRISEPT, NEUROLON FOR SUTURE, VICRYL SUTURE, CRANIOS, MATRIXNEURO PLATING SYSTEM WERE ALSO USED DURING THE CASE. THIS REPORT IS FOR ONE (1) SYNTHECEL® DURA REPAIR 7.5CM X 7.5CM(3" X 3")STERILE. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Local Reaction; Skin Inflammation/ Irritation

  MAUDE report 12745928 ↗

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-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
• 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-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-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-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