MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2018-12-19 for 1.5 MM SYSTEM 18.5 MM BURR HOLE PLATE N/A 01-7308 manufactured by Biomet Microfixation.
[130785487]
(b)(4). Device product code: hbw. (b)(4). Concomitant medical device: oxford performance materials htr-pekk rickers right frontal sphenoid parietal temporal implant, catalog #: pk620833, lot #: 202354; biomet microfixation 1. 5 mm system 2 hole long straight plate, catalog #: 01-7347, lot #: ni; biomet microfixation 1. 5 mm system high torque (ht), sd, x-dr, screw 1. 5 mm x 4 mm, catalog #: 91-6104, lot #: ni. Customer has indicated that the product will not be returned to zimmer biomet for investigation, it 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: 0001032347-2018-00876 and 0001032347-2018-00877.
Patient Sequence No: 1, Text Type: N, H10
[130785488]
It was reported a revision was performed due to an infection. The cranioplasty implant, plates, and screws were removed, the patient was treated for the infection, and new implants were placed. 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 | 0001032347-2018-00875 |
| MDR Report Key | 8178544 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2018-12-19 |
| Date of Report | 2019-02-14 |
| Date Mfgr Received | 2019-01-15 |
| Date Added to Maude | 2018-12-19 |
| 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 | 1.5 MM SYSTEM 18.5 MM BURR HOLE PLATE |
| Generic Name | FASTENER, PLATE, CRANIOPLASTY |
| Product Code | HBW |
| Date Received | 2018-12-19 |
| Model Number | N/A |
| Catalog Number | 01-7308 |
| 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 | 2018-12-19 |