MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-04-16 for HTR PMI R.T.1959 FRONTAL IMPLANT N/A PM621542-A manufactured by Biomet Microfixation.
[142539943]
Zimmer biomet complaint (b)(4). Initial reporter also sent report to fda: the user facility is foreign; therefore a facility medwatch report will not be available. Report source: (b)(6). 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
[142539944]
It was reported that the surgeon was unsatisfied with the fit of the implant in that the implant was an inaccurate design overlapping in the forehead area. No known adverse event was reported. Attempts have been made and no further information has been provided. The surgeon reported the implant was an inaccurate design overlapping in the forehead area.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001032347-2019-00229 |
| MDR Report Key | 8520429 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-04-16 |
| Date of Report | 2019-09-18 |
| Date Mfgr Received | 2019-09-18 |
| Device Manufacturer Date | 2018-12-21 |
| Date Added to Maude | 2019-04-16 |
| 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 | MR. ALAN MUNOZ |
| Manufacturer Street | 1520 TRADEPORT DRIVE |
| Manufacturer City | JACKSONVILLE FL 32218 |
| Manufacturer Country | US |
| Manufacturer Postal | 32218 |
| Manufacturer Phone | 9043677142 |
| 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 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HTR PMI R.T.1959 FRONTAL IMPLANT |
| Generic Name | MATERIAL, POLYTETRAFLUOROETHYLENE VITREOUS CARBON, FOR MAXILLOFACIAL RECONSTRUCT |
| Product Code | KKY |
| Date Received | 2019-04-16 |
| Model Number | N/A |
| Catalog Number | PM621542-A |
| Lot Number | 876550 |
| 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 | 2019-04-16 |