MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2018-09-10 for HTR-PMI JORDAAN RIGHT MAXILLA ZYGOMA ORBITAL IMPLANT N/A PM618014 manufactured by Biomet Microfixation.
[119783408]
(b)(4). (b)(6). Customer has indicated that the product will not be returned to zimmer biomet for investigation. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[119783409]
It was reported a "small piece" of the implant was removed as it was "mobile and causing irritation. " attempts have been made and no further information has been provided. Later a revision to remove the rest of the implant due to loosening and infection was performed (see medwatch #0001032347-2018-00611 and 0001032347-2018-00612). No additional patient consequences were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001032347-2018-00613 |
| MDR Report Key | 7862121 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2018-09-10 |
| Date of Report | 2019-02-21 |
| Date Mfgr Received | 2019-02-15 |
| Device Manufacturer Date | 2016-11-22 |
| Date Added to Maude | 2018-09-10 |
| 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 | MRS. MICHELLE COLE |
| Manufacturer Street | 1520 TRADEPORT DRIVE |
| Manufacturer City | JACKSONVILLE FL 32218 |
| Manufacturer Country | US |
| Manufacturer Postal | 32218 |
| Manufacturer Phone | 9047414400 |
| Manufacturer G1 | BIOMET MICROFIXATION |
| Manufacturer Street | 1520 TRADEPORT DRIVE |
| Manufacturer City | JACKSONVILLE FL 32218 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32218 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HTR-PMI JORDAAN RIGHT MAXILLA ZYGOMA ORBITAL IMPLANT |
| Generic Name | HARD TISSUE REPLACEMENT (HTR) - PATIENT MATCHED IMPLANT |
| Product Code | KKY |
| Date Received | 2018-09-10 |
| Model Number | N/A |
| Catalog Number | PM618014 |
| Lot Number | 721750 |
| Device Expiration Date | 2019-11-22 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET MICROFIXATION |
| Manufacturer Address | 1520 TRADEPORT DRIVE JACKSONVILLE FL 32218 US 32218 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2018-09-10 |