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.
[119783540]
(b)(4). Concomitant medical products: "1. 5 mm" system center-drive screw, 5/pkg, catalog #: 01-7209, lot #: ni. Concomitant medical products: (b)(6) 2018 (anticipated revision date reported, however has not been confirmed at this time). (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. Multiple mdr reports were filed for this event, please see associated report: 0001032347-2018-00612.
Patient Sequence No: 1, Text Type: N, H10
[119783541]
It was reported a revision to remove the implant due to loosening and infection was performed. Attempts have been made and no further information has been provided. No additional patient consequences were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001032347-2018-00611 |
| MDR Report Key | 7862117 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2018-09-10 |
| Date of Report | 2019-02-21 |
| Date Mfgr Received | 2019-02-12 |
| 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 |