MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2016-12-22 for SHOULDER TOWER SUSPENSION SYSTEM AR-1650-01 manufactured by Allen Medical Systems, Inc..
[63133431]
Awaiting the return of the device for root cause evaluation, remediation determination and implementation. A follow-up mdr will be filed.
Patient Sequence No: 1, Text Type: N, H10
[63133432]
Fairly early in the case. Prior to anchor placement. They tried to adjust internal/external rotation several times. The riveted screw on the boom fell out and into the sterile field. There was no known injury/adverse event to the patient due to this incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1221538-2016-00003 |
| MDR Report Key | 6199277 |
| Report Source | DISTRIBUTOR |
| Date Received | 2016-12-22 |
| Date of Report | 2016-12-22 |
| Date of Event | 2016-11-22 |
| Date Mfgr Received | 2016-11-22 |
| Device Manufacturer Date | 2016-02-19 |
| Date Added to Maude | 2016-12-22 |
| 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 |
| Reporter Occupation | SERVICE PERSONNEL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JOHN DRAHOS |
| Manufacturer Street | 100 DISCOVERY WAY |
| Manufacturer City | ACTON MA 01720 |
| Manufacturer Country | US |
| Manufacturer Postal | 01720 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SHOULDER TOWER SUSPENSION SYSTEM |
| Generic Name | SHOULDER TOWER |
| Product Code | FMP |
| Date Received | 2016-12-22 |
| Model Number | AR-1650-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALLEN MEDICAL SYSTEMS, INC. |
| Manufacturer Address | 100 DISCOVERY WAY ACTON MA 01720 US 01720 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-12-22 |