MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-12-18 for STD BRL 4-HOLE PLATE 135 DEG N/A 2110-135-004 manufactured by Biomet Uk Ltd..
[95194586]
(b)(4). Customer has indicated that the product is in process of being returned to zimmer biomet for investigation. 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
[95194587]
It has been reported that during a procedure, the lag screw would not fit through the barrel of the hiploc plate. Another new plate and the same lagscrew was used to complete the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002806535-2017-01209 |
| MDR Report Key | 7125129 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-12-18 |
| Date of Report | 2018-05-22 |
| Date of Event | 2017-09-07 |
| Date Mfgr Received | 2018-05-21 |
| Device Manufacturer Date | 2016-11-28 |
| Date Added to Maude | 2017-12-18 |
| 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 | MS. CHRISTINA ARNT |
| Manufacturer Street | 56 E. BELL DR. |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5745273773 |
| Manufacturer G1 | BIOMET UK LTD. |
| Manufacturer Street | WATERTON INDUSTRIAL ESTATES |
| Manufacturer City | BRIDGEND CF313XA |
| Manufacturer Country | UK |
| Manufacturer Postal Code | CF31 3XA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STD BRL 4-HOLE PLATE 135 DEG |
| Generic Name | DEVICE, FIXATION |
| Product Code | JDO |
| Date Received | 2017-12-18 |
| Model Number | N/A |
| Catalog Number | 2110-135-004 |
| Lot Number | 3918366 |
| ID Number | SEE H10 NARRATIVE |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET UK LTD. |
| Manufacturer Address | WATERTON INDUSTRIAL ESTATES BRIDGEND CF313XA UK CF31 3XA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-12-18 |