MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2008-01-24 for MANUAL ORTHOPEDIC SURGICAL INSTRUMENT 9450020 manufactured by Warsaw Orthopedic, Inc..
[799084]
It was reported that the insulation on the cannula peeled off during the procedure at l4 pedicle. No pt complications were reported.
Patient Sequence No: 1, Text Type: D, B5
[8050273]
Device was returned to the mfr for eval. Visual exam confirmed the peeling.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1030489-2008-00031 |
| MDR Report Key | 984500 |
| Report Source | 07 |
| Date Received | 2008-01-24 |
| Date of Report | 2007-12-17 |
| Date of Event | 2007-12-17 |
| Date Mfgr Received | 2007-12-17 |
| Device Manufacturer Date | 2007-06-15 |
| Date Added to Maude | 2008-09-26 |
| 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 | CHRISTINE SCIFERT, M.S. |
| Manufacturer Street | 1800 PYRAMID PLACE |
| Manufacturer City | MEMPHIS TN 38132 |
| Manufacturer Country | US |
| Manufacturer Postal | 38132 |
| Manufacturer Phone | 9013963133 |
| Manufacturer G1 | WARSAW ORTHOPEDIC INC. |
| Manufacturer Street | 2500 SILVEUS CROSSING |
| Manufacturer City | WARSAW IN 46852 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46852 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MANUAL ORTHOPEDIC SURGICAL INSTRUMENT |
| Generic Name | NIM NEEDLE |
| Product Code | HXK |
| Date Received | 2008-01-24 |
| Returned To Mfg | 2007-12-21 |
| Model Number | NA |
| Catalog Number | 9450020 |
| Lot Number | W07F1155 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 987353 |
| Manufacturer | WARSAW ORTHOPEDIC, INC. |
| Manufacturer Address | 2500 SILVEUS CROSSING WARSAW IN 46852 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-01-24 |