MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2019-02-07 for OMNIPORE SURGICAL IMPLANT - TWO-PIECE CHIN - LARGE OP8322 manufactured by Matrix Surgical Usa.
[135457535]
No further patient complications have been reported. A review of the manufacturing documentation and sterilization documentation for the device in question revealed no deviation from process or non-conformity of product that would have caused or contributed to the adverse event. There is the possibility that clinical factors may have contributed to this event. At this time the cause of the infection is unknown. Based on the information received, the cause of the reported incident could not be conclusively determined. If additional information is received, it will be provided in a supplemental report. Device and packaging was discarded and not available for evaluation. Retained sample from same lot was evaluated for packaging defects. Corrected data: on 02/07/2019 - follow-up to correct manufacturer number on initial submission dated 03/22/2018. Operator of device - remove value of physician. Occupation - removed value of other: distributor. Event problem and evaluation codes - conclusion and method code removed; device and packaging were discarded and not available for evaluation
Patient Sequence No: 1, Text Type: N, H10
[135457536]
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 Sequence No: 1, Text Type: D, B5
| Report Number | 3009383407-2018-00002 |
| MDR Report Key | 8318307 |
| Report Source | DISTRIBUTOR |
| Date Received | 2019-02-07 |
| Date of Report | 2018-12-26 |
| Date of Event | 2018-09-25 |
| Report Date | 2018-11-30 |
| Date Reported to Mfgr | 2018-11-30 |
| Date Mfgr Received | 2018-11-30 |
| Device Manufacturer Date | 2016-06-28 |
| Date Added to Maude | 2019-02-07 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS VICKI CLOUTIER |
| Manufacturer Street | 4025 WELCOME ALL ROAD SUITE 120 |
| Manufacturer City | ATLANTA GA 303491879 |
| Manufacturer Country | US |
| Manufacturer Postal | 303491879 |
| Manufacturer Phone | 9513260131 |
| Manufacturer G1 | MATRIX SURGICAL USA |
| Manufacturer Street | 4025 WELCOME ALL ROAD SUITE 120 |
| Manufacturer City | ATLANTA 303491879 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 303491879 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OMNIPORE SURGICAL IMPLANT - TWO-PIECE CHIN - LARGE |
| Generic Name | HDPE LARGE TWO-PIECE CHIN |
| Product Code | KKY |
| Date Received | 2019-02-07 |
| Model Number | OP8322 |
| Catalog Number | OP8322 |
| Lot Number | 003070616 |
| Device Availability | N |
| Device Age | 27 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MATRIX SURGICAL USA |
| Manufacturer Address | 4025 WELCOME ALL ROAD SUITE 120 ATLANTA GA 303491876 US 303491876 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-02-07 |