MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-07-30 for TIGER 5500 55075-40 manufactured by Corelink, Llc.
[23155112]
No further information could be obtained on the use or the scenario in how this occurred.
Patient Sequence No: 1, Text Type: N, H10
[23155113]
During a surgery on (b)(6) 2014 the surgeon performed a revision surgery for a screw that fractured within the body cavity. The level above the screw had degenerated. The fractured screw was removed and the surgeon re-instrumented the disc space.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1935627-2015-00002 |
| MDR Report Key | 4961336 |
| Date Received | 2015-07-30 |
| Date of Report | 2015-07-29 |
| Date of Event | 2014-02-28 |
| Date Mfgr Received | 2014-03-04 |
| Date Added to Maude | 2015-08-03 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Street | 7606 FORSYTH BLVD. |
| Manufacturer City | ST. LOUIS MO 63105 |
| Manufacturer Country | US |
| Manufacturer Postal | 63105 |
| Manufacturer Phone | 3148635401 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | TIGER |
| Generic Name | PEDICLE SCREW |
| Product Code | MCV |
| Date Received | 2015-07-30 |
| Model Number | 5500 |
| Catalog Number | 55075-40 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CORELINK, LLC |
| Manufacturer Address | ST. LOUIS MO US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-07-30 |