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 2019-03-06 for THINFLAP SYSTEM, THINFLAP, 6 HOLE STRAIGHT PLATE, LONG N/A 19-1040 manufactured by Biomet Microfixation.
[137943552]
(b)(4). (b)(6). Customer has indicated that the product will not be returned to zimmer biomet for investigation as the product was discarded. 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 reports: 0001032347-2019-00138 and 0001032347-2019-00140.
Patient Sequence No: 1, Text Type: N, H10
[137943553]
It was reported a revision occurred due to infection. The implant was removed due to (b)(6) infection a month after implantation. No additional patient consequences were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001032347-2019-00139 |
| MDR Report Key | 8394297 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-03-06 |
| Date of Report | 2019-06-24 |
| Date of Event | 2017-12-02 |
| Date Mfgr Received | 2019-06-11 |
| Device Manufacturer Date | 2015-12-21 |
| Date Added to Maude | 2019-03-06 |
| 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 | THINFLAP SYSTEM, THINFLAP, 6 HOLE STRAIGHT PLATE, LONG |
| Generic Name | PLATE, CRANIOPLASTY, PREFORMED, NON-ALTERABLE |
| Product Code | GWO |
| Date Received | 2019-03-06 |
| Model Number | N/A |
| Catalog Number | 19-1040 |
| Lot Number | 548020 |
| 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. Hospitalization; 2. Required No Informationntervention | 2019-03-06 |