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 2019-03-08 for HTR-PMI VASQUE TORRES LEFT FRONTAL SPHENOID PARIETAL TEMPORAL IMPLANT N/A PM619689 manufactured by Biomet Microfixation.
[138228690]
Zimmer biomet complaint: (b)(4). Event date: (b)(6) 2019; implant date: (b)(6)2019; report source: foreign country: (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
[138228691]
It was reported the implant on the front did not fit well and they had to press. The implant was delivered in (b)(6) 2017 but due to patient problems it could not be placed until 2019. The doctor had to reduce the implant a little before placing, because after almost two years it is logical that the implant would not fit. When trying to place it, the surgeon forced too much and made the wound. The revision due to infection is captured on mfr #0001032347-2019-00158 through 0001032347-2019-00160.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001032347-2019-00161 |
| MDR Report Key | 8403636 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2019-03-08 |
| Date of Report | 2019-07-18 |
| Date Mfgr Received | 2019-07-12 |
| Device Manufacturer Date | 2017-08-01 |
| Date Added to Maude | 2019-03-08 |
| 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 VASQUE TORRES LEFT FRONTAL SPHENOID PARIETAL TEMPORAL IMPLANT |
| Generic Name | MATERIAL, POLYETRAFLOUROETHYLENE VITREOUS CARBON, FOR MAXILLOFACIAL RECONSTRUCTI |
| Product Code | KKY |
| Date Received | 2019-03-08 |
| Model Number | N/A |
| Catalog Number | PM619689 |
| Lot Number | 772860 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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. Required No Informationntervention | 2019-03-08 |