MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2008-08-13 for ALIGNMENT CUP WITH FEMALE PYRAMID MCX00204 manufactured by Ossur H/f.
[886942]
"alignment cup fractured. Half was in the lamination of the socket. " "fell and hit his head into a railing. Patient experiencing neck and shoulder pain, being seen by a doctor. " cpo stated that the patient would reach full recovery.
Patient Sequence No: 1, Text Type: D, B5
[8075767]
Conclusions - reviewed 3 years of complaints files without finding a similar incident.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1836248-2008-00002 |
| MDR Report Key | 1122486 |
| Report Source | 07 |
| Date Received | 2008-08-13 |
| Date of Report | 2008-05-21 |
| Date of Event | 2008-05-01 |
| Date Mfgr Received | 2008-05-21 |
| Device Manufacturer Date | 2005-11-01 |
| Date Added to Maude | 2009-11-18 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | DICK SMITH |
| Manufacturer Street | 910 BURSTEIN DR. |
| Manufacturer City | ALBION MI 49224 |
| Manufacturer Country | US |
| Manufacturer Postal | 49224 |
| Manufacturer Phone | 5176298890 |
| Manufacturer G1 | OSSUR H/F |
| Manufacturer Street | GRJOTHALS 5 |
| Manufacturer City | REYKJAVIK 110 |
| Manufacturer Country | IC |
| Manufacturer Postal Code | 110 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALIGNMENT CUP WITH FEMALE PYRAMID |
| Product Code | ISS |
| Date Received | 2008-08-13 |
| Model Number | MCX00204 |
| Catalog Number | MCX00204 |
| Lot Number | UNKNOWN |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OSSUR H/F |
| Manufacturer Address | REYKJAVIK IC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-08-13 |