MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-01 for 1.5 MM SYSTEM HIGH TORQUE (HT), SD, X-DR, SCREW 1.5 MM X 4 MM N/A 91-6104 manufactured by Biomet Microfixation.
[129028206]
Zimmer biomet complaint (b)(4). Date of event and explant date: it is reported the revision is scheduled for (b)(4) 2018, however this has not been confirmed at this time. Device product code: hbw. Unique identifier (udi) number: (b)(4). Concomitant medical device: biomet microfixation 1. 5 mm system 2 hole long straight plate, catalog #: 01-7347, lot #: 088620; biomet microfixation htr * pmi purifoy right frontal sphenoid parietal temporal implant, catalog #: pm616540, lot #: 606120. Therapy date: unknown. Customer has indicated that the product will not be returned to zimmer biomet for investigation, it remains implanted in the patient. 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: 0001032347-2018-00822 and 0001032347-2018-00823.
Patient Sequence No: 1, Text Type: N, H10
[129028207]
It was reported the patient was involved in an accident/ "wreck" that caused the cranioplasty implant to break. A revision is planned to remove and replace the existing implant. No additional patient consequences were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001032347-2018-00824 |
| MDR Report Key | 8122164 |
| Date Received | 2018-12-01 |
| Date of Report | 2018-11-30 |
| Date Mfgr Received | 2018-11-02 |
| Device Manufacturer Date | 2014-12-09 |
| Date Added to Maude | 2018-12-01 |
| 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 | 0 |
| Brand Name | 1.5 MM SYSTEM HIGH TORQUE (HT), SD, X-DR, SCREW 1.5 MM X 4 MM |
| Generic Name | FASTENER, SCREW, CRANIOPLASTY |
| Product Code | HBW |
| Date Received | 2018-12-01 |
| Model Number | N/A |
| Catalog Number | 91-6104 |
| Lot Number | 672380 |
| 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 | 2018-12-01 |