Strattice Reconstructive Tissue Matrix 0610008Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI M32806100080), received between Oct 4, 2021 and Dec 12, 2023 — classified as 6 injuries.

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

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryDec 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LIMITED INFORMATION WAS REPORTED THROUGH A LEGAL EVENT THAT A PATIENT WAS IMPLANTED WITH STRATTICE ON (B)(6) 2020. THE FORM ALSO INDICATES THAT ON AN UNSPECIFIED DATE, THE STRATTICE IMPLANT HAD BEEN ¿REMOVED OR REVISED¿. NO INFORMATION WAS PROVIDED ON THE INDICATION FOR THE INITIAL SURGERY OR THE REASON FOR THE REMOVAL OR REVISION.

  Patient problems: Adhesion(s); Hernia

  MAUDE report 18311574 ↗
• InjuryNov 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 15/FEB/2024, PMQA RECEIVED NOTIFICATION FROM LEGAL THAT THE PLAINTIFF PROFILE FORM WAS RECEIVED ASSOCIATED WITH THIS EVENT ON (B)(6) 2024. AS PER THE PPF FORM, THE PATIENT UNDERWENT A ¿PERISTOMAL¿ HERNIA SURGERY AND WAS IMPLANTED WITH STRATTICE DEVICE ON (B)(6) 2018. THE PATIENT UNDERWENT AN ¿INJURY (ADHESIONS, RECURRENCE) + EXPLORATORY LAPAROTOMY, EXTENSIVE LYSIS OF ADHESIONS AND ENTEROLYSIS, REPAIR OF PARASTOMAL HERNIA, INCISIONAL HERNIA REPAIR, RECURRENT¿ ON (B)(6) 2022. AS PER THE PPF FORM, THE PATIENT CLAIMS THE IMPLANTATION AND FAILURE OF THE MESH CAUSED ¿ADHESIONS, PAIN, HERNIA RECURRENCE.¿ THE FORM LISTS THE CONDITIONS THAT WERE TREATED WERE ¿HERNIA¿ WITH APPROXIMATE DATES OF TREATMENT BETWEEN 2021 AND 2023. THE PATIENT UNDERWENT TREATMENT FOR ¿HERNIA¿ WITH APPROXIMATE DATES OF TREATMENT BETWEEN 2017 AND 2019.

  Patient problems: Adhesion(s); Hernia

  MAUDE report 18155408 ↗
• InjuryJun 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS FOLLOW UP#1 TO REPORT ON 01/AUG/2023, PMQA RECEIVED NOTIFICATION FROM LEGAL THAT THE PLAINTIFF PROFILE FORM WAS RECEIVED ASSOCIATED WITH THIS EVENT. AS PER THE PPF FORM, THE PATIENT UNDERWENT AN UMBILICAL HERNIA REPAIR AND WAS IMPLANTED WITH STRATTICE DEVICE LOT (B)(6), 0610008 ON (B)(6) 2016. THE PATIENT WAS TREATED FOR ¿PAIN¿, ¿RECURRENCE" AND ¿ADHESIONS¿ AND UNDERWENT A " RECURRENT VENTRAL HERNIA REPAIR WITH MESH, EXPLORATORY LAPAROTOMY, AND LYSIS OF ADHESIONS" ON (B)(6) 2021 AND WAS IMPLANTED WITH A NON-ABBVIE DEVICE, " BARD/DAVOL ¿ VENTRALEX¿. NO "REVISION OR REMOVAL" WAS REPORTED FOR THE NON-ABBVIE DEVICE. NO OTHER INFORMATION WAS REPORTED. AS REPORTED IN THE INITIAL: LIMITED INFORMATION WAS REPORTED THROUGH A LEGAL EVENT THAT A PATIENT WAS IMPLANTED WITH STRATTICE ON (B)(6) 2016. THE FORM ALSO INDICATES THAT ON AN UNSPECIFIED DATE, THE STRATTICE IMPLANT HAD BEEN ¿REMOVED OR REVISED¿. NO INFORMATION WAS PROVIDED ON THE INDICATION FOR THE INITIAL SURGERY OR THE REASON FOR THE REMOVAL OR REVISION.

  Patient problems: Adhesion(s); Hernia

  MAUDE report 17198995 ↗
• InjuryMay 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH A LEGAL EVENT THAT A PATIENT HAD HERNIA REPAIR SURGERY ON OR ABOUT (B)(6) 2016. DURING HERNIA REPAIR SURGERY, THE SURGEON IMPLANTED A STRATTICE MESH, LOT NUMBER SP100427-201. THE RECORDS INDICATE THE DEVICE WAS A STRATTICE MESH. AFTER SURGERY, PATIENT RETURNED TO THE HOSPITAL ON OR ABOUT (B)(6) 2017, FOR A REVISION SURGERY.

  Patient problems: Hernia

  MAUDE report 16860636 ↗
• InjuryApr 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS FOLLOW UP #1 TO REPORT ON 04/APR/2023, PMQA RECEIVED NOTIFICATION FROM LEGAL THAT THE LOT ASSOCIATED WITH THIS EVENT WAS FOUND THROUGH DISCOVERY AND IS SP100080-092. NO OTHER INFORMATION WAS REPORTED. AS REPORTED IN THE INITIAL: IT WAS REPORTED THROUGH A LEGAL EVENT THAT A 61 YEAR OLD MALE PATIENT HAD HERNIA REPAIR SURGERY ON OR ABOUT (B)(6) 2015. DURING THE HERNIA REPAIR SURGERY, THE SURGEON IMPLANTED A STRATTICE MESH. THE RECORDS INDICATE THIS IS A 10 CM X 6 CM STRATTICE BIOLOGIC MESH. AFTER SURGERY, THE PAITENT RETURNED TO THE HOSPITAL ON OR ABOUT (B)(6) 2021, FOR A REVISION SURGERY. NO OTHER INFORMATION WAS REPORTED.

  Patient problems: Hernia

  MAUDE report 16681567 ↗
• InjuryOct 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS FOLLOW UP#1 TO REPORT ON SEPTEMBER 14TH, 2022, PMQA RECEIVED NOTIFICATION FROM LEGAL THAT THE LOT ASSOCIATED WITH THIS EVENT WAS FOUND THROUGH DISCOVERY AND ARE SP100381-175 (9/22/2016 IMPLANT) AND SP100607-052 (10/18/2018 IMPLANT)". NO OTHER INFORMATION WAS REPORTED. SP100381-175 HAS BEEN PROVIDED AS THE FULL VALID LOT NUMBER. THERE IS NO COMPLAINT AGAINST SP100607-052 SINCE THERE WAS NO REPORTED COMPLICATIONS AFTER THE (B)(6) 2018 IMPLANT DATE AND NO RECORD WILL BE OPENED. THIS RECORD IS ASSOCIATED WITH SP100381-175. AS REPORTED IN THE INITIAL: IT WAS REPORTED THROUGH LEGAL, THAT A 61 YEAR OLD MALE PATIENT UNDERWENT HERNIA REPAIR SURGERY ON (B)(6) 2016 AT OAKWOOD HOSPITAL AND MEDICAL CENTER IN DEARBORN, MICHIGAN. THE PATIENT WAS IMPLANTED WITH STRATTICE LOT SP100381-75. THE PATIENT RETURNED TO THE HOSPITAL ON (B)(6) 2018 AND WAS DIAGNOSED WITH A RECURRENT VENTRAL HERNIA REQUIRING REVISION SURGERY AT (B)(6) MEDICAL CENTER IN DEARBORN, MICHIGAN. SP100381-75; HOWEVER, THE SUBLOT IS MISSING A DIGIT ; THEREFORE THE LOT NUMBER IS INVALID.

  Patient problems: Hernia

  MAUDE report 12569036 ↗