MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2019-03-20 for 1.5 SYSTEM HIGH TORQUE (HT), SD, X-DR, SCR,1.5 X 5 MM, 5/PK N/A 95-6105 manufactured by Biomet Microfixation.
[139370685]
(b)(4). Device product code: hbw. Report source - foreign country: (b)(6). 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.
Patient Sequence No: 1, Text Type: N, H10
[139370686]
It was reported three (3) screws fractured during a procedure. Two fragments out of the three screws fractured at the medium point of the threaded part and both fragments remained in the patient body, and one screw squashed the tip. No additional patient consequences were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001032347-2019-00184 |
| MDR Report Key | 8437870 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2019-03-20 |
| Date of Report | 2019-07-22 |
| Date of Event | 2019-02-04 |
| Date Mfgr Received | 2019-07-15 |
| Date Added to Maude | 2019-03-20 |
| 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 SYSTEM HIGH TORQUE (HT), SD, X-DR, SCR,1.5 X 5 MM, 5/PK |
| Generic Name | FASTENER, SCREW, CRANIOPLASTY |
| Product Code | HBW |
| Date Received | 2019-03-20 |
| Model Number | N/A |
| Catalog Number | 95-6105 |
| 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. Other; 2. Required No Informationntervention | 2019-03-20 |