MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-18 for UNK LUPINE ANCHOR manufactured by Depuy Mitek.
[75504405]
Additional narrative: mitek medical safety department discovered this published white paper detailing a historical event in which some mitek devices were implicated. It cannot be confirmed that this issue had been previously reported to mitek, so an adverse event report is being filed to document the experience described in the article. Additional information was requested from the author but none was provided due to privacy rules. At this point in time, no further action is warranted. However, this file will remain receptive to any potential forthcoming information received that is pertinent and germane to this issue. Mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field. Associated medwatch: 1221934-2017-10214.
Patient Sequence No: 1, Text Type: N, H10
[75504406]
This report is being filed after the subsequent review of the following literature article: anterior glenoid rim fracture following use of resorbable devices for glenohumeral stabilization. (b)(4). (b)(6) male that experienced osteolysis around the anchors.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1221934-2017-10215 |
| MDR Report Key | 6577323 |
| Date Received | 2017-05-18 |
| Date of Report | 2017-04-19 |
| Report Date | 2017-04-19 |
| Date Reported to Mfgr | 2017-04-19 |
| Date Mfgr Received | 2017-04-19 |
| Date Added to Maude | 2017-05-18 |
| 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. JENNIFER LAWRENCE |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 5089776860 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | UNK LUPINE ANCHOR |
| Generic Name | MITEK ANCHOR IMPLANTS |
| Product Code | NOV |
| Date Received | 2017-05-18 |
| Catalog Number | UNK LUPINE |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY MITEK |
| Manufacturer Address | 325 PARAMOUNT DRIVE RAYNHAM MA 02767 US 02767 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-05-18 |