MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-05-05 for HA COATED HALF PINS 71070806 manufactured by Smith & Nephew.
[4444723]
Revision surgery was reported for replacement of a pin.
Patient Sequence No: 1, Text Type: D, B5
[11883598]
Patient Sequence No: 1, Text Type: N, H10
[17453969]
.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1020279-2014-00291 |
| MDR Report Key | 3788919 |
| Report Source | 07 |
| Date Received | 2014-05-05 |
| Date of Report | 2014-05-02 |
| Date of Event | 2014-03-25 |
| Date Mfgr Received | 2014-05-02 |
| Device Manufacturer Date | 2011-06-01 |
| Date Added to Maude | 2014-05-05 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS. CARLA SAMUELS |
| Manufacturer Street | 1450 BROOKS ROAD |
| Manufacturer City | MEMPHIS TN 38116 |
| Manufacturer Country | US |
| Manufacturer Postal | 38116 |
| Manufacturer Phone | 9013995076 |
| Manufacturer G1 | SMITH & NEPHEW |
| Manufacturer Street | ALEMANNENSTRASSE 14 |
| Manufacturer City | TUTTLINGEN 78532 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78532 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HA COATED HALF PINS |
| Generic Name | HA PIN {} 6MM {} 35MM X 150MM |
| Product Code | DZK |
| Date Received | 2014-05-05 |
| Catalog Number | 71070806 |
| Lot Number | 11FT07893 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW |
| Manufacturer Address | ALEMANNENSTRASSSE 14 TUTTLINGEN 78532 GM 78532 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2014-05-05 |