MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-06-17 for ANCHOR BOLT 2013-21/ 2103-29-25 * manufactured by Pmt Corp..
[5852175]
The bolt was too short, then too long, needed a thicker one and used pmt bolt; screwed down 6 turns as instructed and transgressed too far into intradural. Could not see distal end, opened via craniotomy to retrieve. Manufacturer response for pmt bolt, anchor bolt (per site reporter)======================
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4864991 |
| MDR Report Key | 4864991 |
| Date Received | 2015-06-17 |
| Date of Report | 2015-06-17 |
| Date of Event | 2015-06-10 |
| Report Date | 2015-06-17 |
| Date Reported to FDA | 2015-06-17 |
| Date Reported to Mfgr | 2015-06-24 |
| Date Added to Maude | 2015-06-24 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ANCHOR BOLT |
| Generic Name | BOLT, ACCESSORY |
| Product Code | GZL |
| Date Received | 2015-06-17 |
| Model Number | 2013-21/ 2103-29-25 |
| Catalog Number | * |
| Lot Number | 052215/ 030215 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PMT CORP. |
| Manufacturer Address | 1500 PARK ROAD CHANHASSEN MN 55317 US 55317 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-06-17 |