MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2011-02-28 for SLX CORTICAL CANCELLOUS TSCD-30-1226S manufactured by Interventional Spine, Inc..
[1885488]
Post operative complaint. X-ray revealed partial thread delamination of the device. Fixation still appears to be stable.
Patient Sequence No: 1, Text Type: D, B5
[9172016]
Root cause: a device meant for cortical/cancellous implantation was placed in a cortical/cortical portion of the foot. When the wire was placed, the wire bent. This bending resulted in excessive friction between the implant and the k-wire when drilling. It should be noted that initially this event was determined to be not reportable. Upon re-review, it was decided that this should be reported.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2032499-2011-00038 |
| MDR Report Key | 2045609 |
| Report Source | 05,07 |
| Date Received | 2011-02-28 |
| Date of Report | 2002-11-19 |
| Date of Event | 2002-11-19 |
| Date Mfgr Received | 2002-11-19 |
| Device Manufacturer Date | 2002-06-01 |
| Date Added to Maude | 2012-02-10 |
| 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 Street | 13700 ALTON PKWY. STE. 160 |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9494720006 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SLX CORTICAL CANCELLOUS |
| Product Code | MRW |
| Date Received | 2011-02-28 |
| Model Number | TSCD-30-1226S |
| Catalog Number | TSCD-30-1226S |
| Lot Number | 061702-A |
| Device Expiration Date | 2004-08-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTERVENTIONAL SPINE, INC. |
| Manufacturer Address | IRVINE CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-02-28 |