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 - MEDIUM OP8321 manufactured by Matrix Surgical Usa.
[135537232]
It was reported that due to the infection, the whole implant was explanted, but was not returned and no further information was made available. The complainant made no indication that the omnipore implant reliability or performance were contributing factors to the adverse event. 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. Despite good faith efforts to obtain additional information, the complainant was unable to provide any further patient or procedural details. 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 were discarded and not available for evaluation. Retained sample from same lot was evaluated for packaging defects. No defects observed. 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. Conclusion and method code removed; device and packaging were discarded and not available for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[135537233]
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 Sequence No: 1, Text Type: D, B5
| Report Number | 3009383407-2018-00001 |
| MDR Report Key | 8318300 |
| Report Source | DISTRIBUTOR |
| Date Received | 2019-02-07 |
| Date of Report | 2018-03-22 |
| Date of Event | 2017-05-07 |
| Date Mfgr Received | 2018-02-21 |
| 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 | 0 |
| 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 GA 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 - MEDIUM |
| Generic Name | MEDIUM TWO-PIECE CHIN |
| Product Code | KKY |
| Date Received | 2019-02-07 |
| Model Number | OP8321 |
| Catalog Number | OP8321 |
| Lot Number | 030070616 |
| Device Availability | N |
| 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 |