MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-18 for THINFLAP SYSTEM CROSS-DRIVE, SELF-DRILLING SCREW 1.5 X 4 MM N/A 91-6704 manufactured by Biomet Microfixation.
[131216592]
Zimmer biomet complaint (b)(4). Device product code: (b)(4). Unique identifier (udi) number: (b)(4). Foreign country: (b)(6) customer has indicated that the product is in process of being returned to zimmer biomet for investigation. Once the investigation has been completed, a follow-up mdr will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[131216593]
It was reported the screw head was unable to be gripped during a surgery on a cranium. Attempts have been made and no further information has been provided. No adverse events have been reported as a result of the malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001032347-2018-00874 |
| MDR Report Key | 8174330 |
| Date Received | 2018-12-18 |
| Date of Report | 2019-02-08 |
| Date of Event | 2018-08-15 |
| Date Mfgr Received | 2019-01-11 |
| Date Added to Maude | 2018-12-18 |
| 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 | THINFLAP SYSTEM CROSS-DRIVE, SELF-DRILLING SCREW 1.5 X 4 MM |
| Generic Name | FASTENER, SCREW, CRANIOPLASTY |
| Product Code | HBW |
| Date Received | 2018-12-18 |
| Returned To Mfg | 2018-12-27 |
| Model Number | N/A |
| Catalog Number | 91-6704 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-12-18 |