MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2007-10-12 for SPARLING RONGEUR NL4071-082 manufactured by .
[689217]
During surgery a piece (footplate) of a rongeur broke off and retrieved from the surgical site. No add'l surgery was required, and the patient recovered without complications. The rongeur was delivered to reprocessing who notified the manufacturer's rep of the event and gave him the instrument.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 931155 |
| MDR Report Key | 931155 |
| Report Source | 99 |
| Date Received | 2007-10-12 |
| Date of Report | 2007-10-09 |
| Date of Event | 2007-08-08 |
| Date Facility Aware | 2007-08-09 |
| Report Date | 2007-10-09 |
| Date Reported to Mfgr | 2007-10-09 |
| Date Added to Maude | 2007-10-29 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPARLING RONGEUR |
| Generic Name | BONE NIPPERS |
| Product Code | JYR |
| Date Received | 2007-10-12 |
| Returned To Mfg | 2007-09-19 |
| Model Number | NL4071-082 |
| Device Availability | R |
| Device Age | 6 YR |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 904895 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-10-12 |