MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2013-09-12 for SPF SPINAL FUSION STIMULATOR N/A 10-1398M manufactured by Ebi, Llc..
[3814073]
It was reported that upon post-op review of spinal fusion case, it was discovered that there was disassociation of the pedicle screws heads. Patient outcome: no information has been provided at this time.
Patient Sequence No: 1, Text Type: D, B5
[11174515]
No product was returned to manufacturer. Current information is insufficient to permit a conclusion as to the cause of the event. Implant date - unknown. Explanted date - still implanted. This report is number 1 of 6 mdrs filed for the same event (also see 0002242816-2013-00110 / 00115).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0002242816-2013-00115 |
| MDR Report Key | 3345042 |
| Report Source | 07 |
| Date Received | 2013-09-12 |
| Date of Report | 2013-08-27 |
| Date of Event | 2013-08-27 |
| Date Mfgr Received | 2013-08-27 |
| Date Added to Maude | 2013-12-18 |
| 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 (MINI) |
| Product Code | LOE |
| Date Received | 2013-09-12 |
| 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 | 2013-09-12 |