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 6 HOLE STRAIGHT PLATE, LONG N/A 19-1040 manufactured by Biomet Microfixation.
[138074218]
Zimmer biomet complaint (b)(4). Device product code: hbw. Foreign country: (b)(6). Customer has indicated that the product will not be returned to zimmer (b)(4) for investigation. 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:0001032347-2019-00141, 0001032347-2019-00151, & 0001032347-2019-00152.
Patient Sequence No: 1, Text Type: N, H10
[138074219]
It was reported a revision will occur due to the patient evolving with an infectious disease. This patient is planned to be implanted with a pekk implant. Attempts have been made and no further information has been provided. No additional patient consequences were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001032347-2019-00150 |
| MDR Report Key | 8396578 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-03-06 |
| Date of Report | 2019-07-01 |
| 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 6 HOLE STRAIGHT PLATE, LONG |
| Generic Name | FASTENER, PLATE, CRANIOPLASTY |
| Product Code | HBW |
| 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 |