MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-01-23 for BIOSTOP G RESTR TRIAL 14MM 5463-34-500 546334500 manufactured by Depuy Orthopaedics Inc Us.
[184936876]
Product complaint #: (b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Investigation summary: the device associated with this report was not returned, thus the reported event could not be confirmed. The investigation could not verify or identify any product contribution to the reported event with the information provided. Depuy synthes considers the investigation closed at this time. Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.
Patient Sequence No: 1, Text Type: N, H10
[184936877]
The metal restrictor that was used for the placement of the biostop plug has accidentally been left inside the femoral canal.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2020-02720 |
| MDR Report Key | 9623513 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-23 |
| Date of Report | 2020-01-21 |
| Date Mfgr Received | 2020-01-21 |
| Date Added to Maude | 2020-01-23 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KARA DITTY-BOVARD |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 465810988 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810988 |
| Manufacturer Phone | 6107428552 |
| Manufacturer G1 | DEPUY ORTHOPAEDICS, INC. 1818910 |
| Manufacturer Street | 700 ORTHOPAEDIC DR. |
| Manufacturer City | WARSAW IN 465810988 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 465810988 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIOSTOP G RESTR TRIAL 14MM |
| Generic Name | MISCELLANEOUS JOINT INSTRUMENTS : CEMENT DELIVERY DEVICES |
| Product Code | KIH |
| Date Received | 2020-01-23 |
| Model Number | 5463-34-500 |
| Catalog Number | 546334500 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY ORTHOPAEDICS INC US |
| Manufacturer Address | 700 ORTHOPAEDIC DRIVE WARSAW IN 465810988 US 465810988 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-23 |