MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-01-17 for SPF SPINAL FUSION STIMULATOR N/A 10-1398M manufactured by Ebi, Llc..
[4061208]
It was reported that patient developed cyst and abscess formation in the area of spf implant post-op. Patient outcome: no information has been provided at this time
Patient Sequence No: 1, Text Type: D, B5
[11444373]
No product was returned to manufacturer. Current information is insufficient to permit a conclusion as to the cause of the event. Date of event - unknown. Expiration date - unknown. Implant date - (b)(6) 2013 (exact date unknown). Explant date - unknown. Device manufacture date? Unknown.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0002242816-2014-00003 |
| MDR Report Key | 3582204 |
| Report Source | 05 |
| Date Received | 2014-01-17 |
| Date of Report | 2013-12-18 |
| Date Mfgr Received | 2013-12-18 |
| Date Added to Maude | 2014-01-17 |
| 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 | MR. DAVID TALISH |
| Manufacturer Street | 399 JEFFERSON ROAD |
| Manufacturer City | PARSIPPANY NJ 07054 |
| Manufacturer Country | US |
| Manufacturer Postal | 07054 |
| Manufacturer Phone | 9732999300 |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPF SPINAL FUSION STIMULATOR |
| Generic Name | SPF-PLUS 60/M |
| Product Code | LOE |
| Date Received | 2014-01-17 |
| Model Number | N/A |
| Catalog Number | 10-1398M |
| Lot Number | N/A |
| ID Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EBI, LLC. |
| Manufacturer Address | 399 JEFFERSON ROAD PARSIPPANY NJ 07054 US 07054 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-01-17 |