MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2017-10-17 for 12.5MM LAG SCREW N/A 236100 manufactured by Biomet Uk Ltd..
[90541321]
(b)(4). (b)(6). 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: 3002806535-2017-00952.
Patient Sequence No: 1, Text Type: N, H10
[90541322]
It was reported that during a procedure, the lag screw could not be passed through the barrel of the plate. Another lag screw and plate were used to complete the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002806535-2017-00953 |
| MDR Report Key | 6955618 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2017-10-17 |
| Date of Report | 2018-05-16 |
| Date of Event | 2017-09-15 |
| Date Mfgr Received | 2018-05-15 |
| Date Added to Maude | 2017-10-17 |
| 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 | 12.5MM LAG SCREW |
| Generic Name | DEVICE, FIXATION |
| Product Code | JDO |
| Date Received | 2017-10-17 |
| Model Number | N/A |
| Catalog Number | 236100 |
| Lot Number | 2016110033 |
| ID Number | N/A |
| Operator | PHYSICIAN |
| Device Availability | N |
| 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 | 2017-10-17 |