MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07,08 report with the FDA on 2014-08-04 for PCLS SZ. 10 PYROSPHERE manufactured by Ascension Orthopedics, Inc..
[19724279]
It was reported. We had a pyrosphere case where the implant was "radiolucent" on x-ray. Another implant was opened and came up as it should on x-ray. Additional information was requested by integra and received from the distributor on (b)(6) 2014. This was detected intra operatively. The first implant was explanted and a new one put in and surgery was completed successfully prior to closure. The surgery time was increased by approximately 30 minutes. There was no injury or adverse consequences to the patient reported.
Patient Sequence No: 1, Text Type: D, B5
[19821816]
The device involved in the reported incident has not been received for evaluation. An investigation has been initiated based upon the reported information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1651501-2014-00036 |
| MDR Report Key | 4212741 |
| Report Source | 01,07,08 |
| Date Received | 2014-08-04 |
| Date of Report | 2014-07-17 |
| Date of Event | 2014-06-26 |
| Date Mfgr Received | 2014-07-17 |
| Date Added to Maude | 2014-11-03 |
| 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 | CAREN FINKELSTEIN |
| Manufacturer Street | 315 ENTERPISE DRIVE |
| Manufacturer City | PLANSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362341 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PCLS SZ. 10 PYROSPHERE |
| Generic Name | PYROSPHERE |
| Product Code | KYI |
| Date Received | 2014-08-04 |
| Returned To Mfg | 2014-07-23 |
| Device Expiration Date | 2017-12-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ASCENSION ORTHOPEDICS, INC. |
| Manufacturer Address | AUSTIN TX 78754383 US 78754 3832 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-08-04 |