MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-03-01 for * H9102 manufactured by Linvatec Corporation.
[21981079]
As the physician used the linvatec disposable bur, metal shavings were witnessed from the the bur inside the shoulder joint. The physician stopped using and thoroughly washed out the shoulder. What was the original intended procedure? Shoulder arthroscopy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003752 |
| MDR Report Key | 3003752 |
| Date Received | 2013-03-01 |
| Date of Report | 2013-03-01 |
| Date of Event | 2013-02-21 |
| Report Date | 2013-03-01 |
| Date Reported to FDA | 2013-03-01 |
| Date Reported to Mfgr | 2013-03-14 |
| Date Added to Maude | 2013-03-14 |
| 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 |
| 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 | * |
| Generic Name | BURR, ORTHOPEDIC, ARTHOSCOPY |
| Product Code | HTT |
| Date Received | 2013-03-01 |
| Returned To Mfg | 2013-03-01 |
| Model Number | H9102 |
| Catalog Number | H9102 |
| Lot Number | 410057 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | 1 DY |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LINVATEC CORPORATION |
| Manufacturer Address | 11155 CONCEPT BLVD. LARGO FL 33773 US 33773 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-03-01 |