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 2018-11-27 for BIOMET MICROFIXATION NEURO PLATING SYSTEM N/A UNKNOWN manufactured by Biomet Microfixation.
[128406624]
Zimmer biomet complaint (b)(4). Device product code: hbw. Implant date: (b)(6) 2018. Concomitant medical products: oxford performance materials (opm) htr-pekk nette bi-frontal, catalog #: pk621143, lot #: 203152. Biomet microfixation plates, catalog #: unknown, lot #: unknown. Biomet microfixation screws, catalog #: unknown, lot #: unknown. Therapy date: unknown. Foreign country: (b)(6). Customer has indicated that the product will not be returned to zimmer biomet for investigation; the hospital does not wish to release the product. 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
[128406625]
It was reported a revision was performed due to an infection in combination with a wound healing disorder. It was stated this happened because "the patient did not follow all surgeons' instructions. " a remake of the same implant was requested. No additional patient consequences were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001032347-2018-00807 |
| MDR Report Key | 8105792 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-11-27 |
| Date of Report | 2018-11-27 |
| Date Mfgr Received | 2018-10-30 |
| Date Added to Maude | 2018-11-27 |
| 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 | BIOMET MICROFIXATION NEURO PLATING SYSTEM |
| Generic Name | FASTENER, SCREW, CRANIOPLASTY |
| Product Code | HBW |
| Date Received | 2018-11-27 |
| Model Number | N/A |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| 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 | 2018-11-27 |