OmniPore Surgical ImplantRecalls & reported problems across all models
Matrix Surgical Holdings, LLC · 9 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 11
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls
- 3
We found 9 models of OmniPore Surgical Implant by Matrix Surgical Holdings, LLC in the FDA's device registry (GUDID). Together they are named in 11 adverse event reports in the FDA's MAUDE database, received between Oct 25, 2017 and Apr 25, 2024 — classified as 8 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (5 reports).
3 FDA recall records name at least one of these models by its device identifier.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
OmniPore Surgical Implant recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jan 30, 2019Class IITerminated
Product mislabeling.
Z-1224-2019 · Root cause: Employee error · Recall details · FDA record ↗
- Jan 30, 2019Class IITerminated
Product mislabeling.
Z-1223-2019 · Root cause: Employee error · Recall details · FDA record ↗
- Jan 25, 2017Class IITerminated
Mislabeling. The packaging labeled as left mandible contained a right mandible.
Z-1382-2017 · Root cause: Other · names 2 of these models · Recall details · FDA record ↗
Most reported OmniPore Surgical Implant problems
Device problems
- Insufficient Device Problem Information5
- Adverse Event Without Identified Device or Use Problem4
- Appropriate Device Problem Term/Code Not Available2
- Fracture2
- Unsealed Device Packaging1
Patient problems
- No Patient Involvement3
- Post Operative Wound Infection3
- Edema2
- Failure of Implant2
- Inflammation2
- Patient Problem/Medical Problem2
- Discomfort1
- Insufficient Information1
OmniPore Surgical Implant models
9 models, most reported first. Each model has its own page with its reports, recalls and device details.
- OmniPore Surgical Implant OP7544Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction1 recall1 report
- OmniPore Surgical Implant OP9519Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction1 recall1 report
- OmniPore Surgical Implant OP9520Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction1 recall1 report
- OmniPore Surgical Implant OP7543Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction1 recall0 reports
- OmniPore Surgical Implant OP8330Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction3 reports
- OmniPore Surgical Implant OP8322Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction2 reports
- OmniPore Surgical Implant OP8321Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction1 report
- OmniPore Surgical Implant OP7542Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction1 report
- OmniPore Surgical Implant OP82011Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction1 report
Recent OmniPore Surgical Implant adverse event reports
The 11 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryApr 25, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
ACCORDING TO THE INITIAL REPORT, THE PROSTHESIS BROKE INSIDE THE PATIENT WHEN THE SURGEON WAS FIXINFG IT. THE SURGEON WAS UNABLE TO REPLACE IT WHICH CREATED AESTHETIC IMPERFECTIONS .
Patient problems: Discomfort; Insufficient Information
MAUDE report 19183395 ↗InjurySep 1, 2021Fracture; Fracture
ACCORDING TO THE INITIAL REPORT, THE SURGEON STATED THAT A PATIENT EXPERIENCED AN IMPLANT FRACTURE AND NEEDED A REPLACEMENT FOR SURGICAL INTERVENTION.
Patient problems: Failure of Implant
MAUDE report 12408172 ↗InjurySep 1, 2021Fracture; Fracture
ACCORDING TO THE INITIAL REPORT, THE SURGEON STATED THAT A PATIENT EXPERIENCED AN IMPLANT FRACTURE AND NEEDED A REPLACEMENT FOR SURGERY INTERVENTION.
Patient problems: Failure of Implant
MAUDE report 12407603 ↗InjuryAug 27, 2021Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE INITIAL REPORT, A PATIENT IS UNDERGOING A SURGERY REVISION DUE TO AN INFECTION OF A RIGHT MANDIBULAR IMPLANT. THE DEVICE WAS IMPLANTED ON (B)(6) 2021 AND THE INFECTION WAS REPORTED ON JUNE 27TH 2021.
Patient problems: Post Operative Wound Infection
MAUDE report 12379608 ↗InjuryDec 3, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
ACCORDING TO THE INITIAL REPORT, A KOREAN PATIENT WITH AN INFECTION THAT NEEDS HIS IMPLANT REPLACED. THERE WAS AN EXPOSURE THAT LED TO IMPLANT CONTAMINATION. NOT A REAL INFECTION.
Patient problems: Post Operative Wound Infection
MAUDE report 9401291 ↗MalfunctionFeb 22, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
THIS REPORT INITIATED FOR THE "POATIENAIL" THAT THE OP9519 PETITE PARANASAL - RIGHT MAY BE LABELED AS OP9520 PETITE PARANASAL - RIGHT. ON (B)(6) 2019, A PHYSICIAN REPORTED TO OUR (B)(4) DISTRIBUTOR THAT A OP9520 PETITE PARANASAL - RIGHT WAS LABELED AS A OP9519 PETITE PARANASAL - LEFT. THE SPECIFIC REPORTED INFORMATION FROM THE DISTRIBUTOR'S EMAIL WAS: "OUR CLIENT CLAIMED THE IMPLANT (REF: OP9519) WAS NOT LABELED CORRECTLY. OP9519 SHALL BE PETITE PARANASAL-LEFT, HOWEVER HE FOUND OP9519 AND OP9520 WERE EXACT SAME FOR PARANASAL RIGHT WHILE OPENED THE STERILIZED PACKING".
Patient problems: No Patient Involvement
MAUDE report 8362666 ↗MalfunctionFeb 22, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ON (B)(6) 2019, A PHYSICIAN REPORTED TO OUR (B)(4) DISTRIBUTOR THAT A OP9520 PETITE PARANASAL - RIGHT WAS LABELED AS A OP9619 PETITE PARANASAL - LEFT. THE SPECIFIC REPORTED INFORMATION FROM THE DISTRIBUTOR'S EMAIL WAS: "OUR CLIENT CLAIMED THE IMPLANT (REF: OP9519)WAS NOT LABELED CORRECTLY. OP9519 SHALL BE PETITE PARANASAL-LEFT, HOWEVER HE FOUND OP9519 AND OP9520 WERE EXACT SAME FOR PARANASAL RIGHT WHILE OPENED THE STERILIZED PACKAGING".
Patient problems: No Patient Involvement
MAUDE report 8362604 ↗InjuryFeb 22, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
PHONE CALL MESSAGE WAS RECEIVED BY (B)(6) (VP MARKETING) ON (B)(6) 2019 FROM SURGEON REPORTING THAT A PATIENT HAD DEVELOPED A POST-OPERATIVE INFECTION AFTER THE IMPLANTATION OF THE TWO-PIECE CHIN. NO OTHER INFORMATION WAS RECEIVED AT THE TIME OF THIS INITIAL CONTACT. PRODUCT INFORMATION WAS MADE AVAILABLE BY THE REVIEW OF DISTRIBUTION RECORDS.
Patient problems: Patient Problem/Medical Problem; Post Operative Wound Infection
MAUDE report 8362264 ↗InjuryFeb 7, 2019Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
EMAIL NOTIFICATION WAS RECEIVED FROM OUR DISTRIBUTOR (B)(4) ON NOV. 30, 2018 INDICATING THAT A PATIENT DEVELOPED A POST-SURGICAL INFECTION POST THE IMPLANT OF AN OMNIPORE TWO-PIECE CHIN (OP8322). THE FOLLOWING INFORMATION WAS RECEIVED: THE SURGEON REPORTED THAT THEY FOLLOWED THE PROTOCOL BUT EVEN SO COULD NOT MOLD THE PRODUCT WHICH WAS EXTREMELY HARD EVEN WARMED. AFTER IMPLANTATION, THE PROTHESIS GOT A SPACE BETWEEN IT AND THE BONE. AFTER SURGERY, IN THE SPACE BETWEEN THE PROTHESIS AND THE BONE, THE PATIENT BEGAN TO HAVE AN INFLAMMATORY REACTION, EDEMA AND PAIN. SO THEN, THE SURGEON REMOVED THE IMPLANT AND DISCARDED IT. DATE OF SURGERY: (B)(6) 2018. PATIENT´S NAME: (B)(6). SURGEON´S NAME: (B)(6). PRODUCT CODE: OP8322. LOT: 9003070616.
Patient problems: Edema; Inflammation; Patient Problem/Medical Problem
MAUDE report 8318307 ↗InjuryFeb 7, 2019Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
EMAIL NOTIFICATION WAS RECEIVED FROM OUR DISTRIBUTOR (B)(4) ON FEB. 21, 2018 INDICATING THAT A PHYSICIAN REPORTED PATIENT DEVELOPED A POST-SURGICAL INFECTION AFTER THE IMPLANTATION OF AN OMNIPORE TWO-PIECE CHIN (OP8321). DEVICE WAS IMPLANTED ON (B)(6) 2017. IT WAS REPORTED THAT 1 MONTH AFTER SURGERY THE PATIENT BEGAN TO HAVE AN INFLAMMATORY REACTION, SECRETION, EDEMA AND SWELLING. THE PHYSICIAN DRAINED THE SITE AND PRESCRIBED ANTIBIOTIC. THE PATIENT HAD AN IMPROVEMENT FOR 15 DAYS, THEN CAME BACK PRESENTING THE SAME INFLAMMATORY CONDITION. THE PHYSICIAN PERFORMED A SURGERY REMOVING AND CLEANING THE IMPLANTED DEVICE, TREATING PATIENT WITH ANTIBIOTIC, AND RE-IMPLANTED THE ORIGINAL DEVICE. AFTER 2 WEEKS, PATIENT RETURNED WITH ALL THE SAME REACTIONS AND ON (B)(6) 2018 THE IMPLANTED DEVICE WAS REMOVED. TODAY THE PATIENT IS WELL.
Patient problems: Edema; Inflammation; Unspecified Infection
MAUDE report 8318300 ↗MalfunctionOct 25, 2017Unsealed Device Packaging; Unsealed Device Packaging
ON SEPTEMBER 27, 2017, IT WAS REPORTED BY OUR CONTRACT DISTRIBUTOR (B)(4) IN (B)(4) THAT THE OUTER POUCH FOR PART CRANIOTOMY GAP WEDGES (OP82011); LOT 00855421005727 018141116 WAS NOT SEALED. NO PATIENT OR END USER INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 6977258 ↗
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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