MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-17 for OMNIPORE SURGICAL IMPLANT 9516 manufactured by Matrix Surgical Usa.
[145481665]
This investigation is currently ongoing. Any additional information will be provided in the follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[145481666]
According to the initial report, a (b)(6)-year old female patient was diagnosed with a post-operative infection on (b)(6) 2019 following a malar implantation procedure on (b)(6) 2019. Symptoms included pain, drainage, and fever. The implant was removed on (b)(6) 2019. The report indicates that there was adequate tissue for the covering of the implant without excess tension. There was no previous trauma or scarring to impacted tissue. The surgeon administered an intraoral surgical approach. Screws were used to fixate the implant. Additionally, the hospital does have procedures in place to prevent infection and for sterile device handling. There was no nonviable tissue in the wound and no hematoma formation. No other complications were noted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009383407-2019-00005 |
| MDR Report Key | 8621712 |
| Date Received | 2019-05-17 |
| Date of Report | 2019-05-01 |
| Date of Event | 2019-02-27 |
| Date Mfgr Received | 2019-03-28 |
| Date Added to Maude | 2019-05-17 |
| 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. KEENA MCCURN |
| Manufacturer Street | 4025 WELCOME ALL RD. STE# 120 |
| Manufacturer City | ATLANTA GA 303491879 |
| Manufacturer Country | US |
| Manufacturer Postal | 303491879 |
| Manufacturer Phone | 4048554592 |
| Manufacturer G1 | MATRIX SURGICAL USA |
| Manufacturer Street | 4025 WELCOME ALL RD. STE# 120 |
| Manufacturer City | ATLANTA GA 303491849 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 303491849 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | OMNIPORE SURGICAL IMPLANT |
| Generic Name | MALAR IMPLANT |
| Product Code | LZK |
| Date Received | 2019-05-17 |
| Model Number | 9516 |
| Lot Number | 013010118 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MATRIX SURGICAL USA |
| Manufacturer Address | 4025 WELCOME ALL RD. STE# 120 ATLANTA 30349 US 30349 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other; 3. Required No Informationntervention | 2019-05-17 |