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 2019-08-09 for HTR-PMI G.S.1958 RIGHT FRONTAL PARIETAL SPHENOID TEMPORAL N/A PM621552 manufactured by Biomet Microfixation.
| Report Number | 0001032347-2019-00386 |
| MDR Report Key | 8878953 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-08-09 |
| Date of Report | 2019-10-29 |
| Date Mfgr Received | 2019-10-14 |
| Device Manufacturer Date | 2018-12-18 |
| Date Added to Maude | 2019-08-09 |
| 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. JENNIFER DELANEY |
| 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 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HTR-PMI G.S.1958 RIGHT FRONTAL PARIETAL SPHENOID TEMPORAL |
| Generic Name | CUSTOM MADE HTR |
| Product Code | KKY |
| Date Received | 2019-08-09 |
| Model Number | N/A |
| Catalog Number | PM621552 |
| Lot Number | 874190 |
| 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 | 2019-08-09 |