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 2018-11-16 for HTR-PMI ALONSO FERNAND RIGHT FRONTAL PARIETAL ORBITAL N/A PM620483-A manufactured by Biomet Microfixation.
[127559810]
(b)(4). Foreign country: (b)(6). Customer has indicated that the product will not be returned to zimmer biomet for investigation, it was implanted in the patient. 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
[127559811]
It was reported the implant was found fractured upon opening the package. The surgeon chose to place the broken implant as best as he could instead of using the backup implant, which was not broken. No adverse events have been reported as a result of the malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001032347-2018-00797 |
| MDR Report Key | 8078436 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2018-11-16 |
| Date of Report | 2018-11-16 |
| Date of Event | 2018-10-17 |
| Date Mfgr Received | 2018-10-17 |
| Device Manufacturer Date | 2018-03-27 |
| Date Added to Maude | 2018-11-16 |
| 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 ALONSO FERNAND RIGHT FRONTAL PARIETAL ORBITAL |
| Generic Name | MATERIAL, POLYETRAFLOUROETHYLENE VITREOUS CARBON, FOR MAXILLOFACIAL RECONSTRUCTI |
| Product Code | KKY |
| Date Received | 2018-11-16 |
| Model Number | N/A |
| Catalog Number | PM620483-A |
| Lot Number | 821320 |
| 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 | 2018-11-16 |