MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-11-29 for EBI SPF-PLUS 60/M 010336.C11 12/05 REF10-1398M manufactured by Ebi Patient Care, Inc..
[2457877]
Implantable spinal fusion stimulator placed approximately 3 1/2 years ago at another facility. Stimulator and hardware removed at reporting facility because of two broken s1 screws. Pt had been having low back pain (unknown length of time). Or notified risk management dept of event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2363258 |
| MDR Report Key | 2363258 |
| Date Received | 2011-11-29 |
| Date of Report | 2011-11-29 |
| Date of Event | 2008-06-28 |
| Report Date | 2011-11-29 |
| Date Reported to FDA | 2011-11-29 |
| Date Added to Maude | 2011-12-08 |
| 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 | 0 |
| Reporter Occupation | RISK MANAGER |
| 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 | EBI SPF-PLUS 60/M |
| Generic Name | IMPLANTABLE SPINAL FUSION STIMULATOR |
| Product Code | LOE |
| Date Received | 2011-11-29 |
| Model Number | 010336.C11 12/05 |
| Catalog Number | REF10-1398M |
| Lot Number | P/N 010193.B00 6/99 |
| ID Number | * |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EBI PATIENT CARE, INC. |
| Manufacturer Address | 100 INTERPACE PKWY. PARSIPPANY NJ 07054 US 07054 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-11-29 |