MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2006-09-19 for ASCENSION PCS PCS-10 manufactured by Ascension Orthopedics, Inc..
[512587]
Dr reported on 3/17/2006 that he had a problem with a pcs and would be sending it back. On the following day, ascension was informed that this was a revision performed due to pain.
Patient Sequence No: 1, Text Type: D, B5
[7791921]
Significant delay between time of event and first contact by surgeon. Unable to get response from surgeon for another five months as to whether this device had been implanted. No records for device provided that would allow lot indentification. Cause for revision was pain, but evaluation of explanted device did not indicate that the implant could have contributed to this.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1651501-2006-00004 |
| MDR Report Key | 764660 |
| Report Source | 05 |
| Date Received | 2006-09-19 |
| Date of Report | 2006-09-18 |
| Date of Event | 2006-01-12 |
| Date Mfgr Received | 2006-08-18 |
| Date Added to Maude | 2006-09-28 |
| 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 | 0 |
| Manufacturer Contact | GLEN NELLY |
| Manufacturer Street | 8700 CAMERON RD, C-1040 |
| Manufacturer City | AUSTIN TX 78754 |
| Manufacturer Country | US |
| Manufacturer Postal | 78754 |
| Manufacturer Phone | 5128365001 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ASCENSION PCS |
| Generic Name | WRIST JOINT CARPAL TRAPEZIUM IMPLANT |
| Product Code | KWM |
| Date Received | 2006-09-19 |
| Returned To Mfg | 2006-04-03 |
| Model Number | PCS-10 |
| Catalog Number | PCS-10 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 752518 |
| Manufacturer | ASCENSION ORTHOPEDICS, INC. |
| Manufacturer Address | 8700 CAMERON RD C-1040 AUSTIN TX 78754 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-09-19 |