MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2009-11-03 for CUSHING RONG 7 2X10MM STR 280405 manufactured by J. Jamner Surgical Instruments.
[15626989]
Initially notified of the event by receipt of maude event report form for voluntary report no (b)(4). Copy of the customer medwatch states that "the pt was having a three level discectomy and fusion. During the procedure, the instrument broke off in the pt's disc space. The surgeon was able to remove the broken piece and determined that there was no harm to the pt. Surgery was completed without any further incidents.
Patient Sequence No: 1, Text Type: D, B5
[15824039]
To date, the device involved in the reported incident has not been rec'd for eval. An investigation has been initiated based on the reported info.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2430952-2009-00021 |
| MDR Report Key | 1591220 |
| Report Source | 06 |
| Date Received | 2009-11-03 |
| Date of Report | 2009-11-03 |
| Date of Event | 2009-07-22 |
| Date Facility Aware | 2009-10-15 |
| Date Mfgr Received | 2009-10-15 |
| Date Added to Maude | 2011-03-02 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | SANDRA LEE, RN, BSM |
| Manufacturer Street | 311 ENTERPRISE DR |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099366828 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CUSHING RONG 7 2X10MM STR |
| Generic Name | NA |
| Product Code | HFG |
| Date Received | 2009-11-03 |
| Catalog Number | 280405 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | J. JAMNER SURGICAL INSTRUMENTS |
| Manufacturer Address | HAWTHORNE NY 10532 US 10532 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-11-03 |