MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2020-02-14 for 1.5MM SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW N/A 91-1509 manufactured by Biomet Microfixation.
[179452363]
(b)(4). The device will not be returned for analysis as it was discarded by the hospital; however, an investigation of the reported event is in progress. Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[179452364]
It was reported that a screw fractured upon insertion into the anterior ramus of the patient's mandible. The surgeon trephined around the retained screw body to facilitate removal of the screw fragment. No additional patient consequences were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001032347-2020-00110 |
| MDR Report Key | 9711285 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-02-14 |
| Date of Report | 2020-02-14 |
| Date of Event | 2020-01-08 |
| Date Mfgr Received | 2020-01-16 |
| Date Added to Maude | 2020-02-14 |
| 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. JENNIFER DELANEY |
| 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 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 1.5MM SYSTEM HIGH TORQUE (HT) CROSS-DRIVE SCREW |
| Generic Name | PLATE, BONE |
| Product Code | JEY |
| Date Received | 2020-02-14 |
| Model Number | N/A |
| Catalog Number | 91-1509 |
| Lot Number | UNKNOWN |
| 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. Required No Informationntervention | 2020-02-14 |