MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,04 report with the FDA on 2013-04-01 for SPF SPINAL FUSION STIMULATOR N/A 10-1398M manufactured by Ebi, Llc..
[10740135]
A visual inspection of the above-mentioned customer returned item was performed. The unit showed signs of use and the leads were in contact with unit. A review of the manufacturing records were reviewed and indicate that the unit was manufactured on july 5, 2005. No discrepancies were reported at the time of inspection in 2005. The unit expiration date is july 5, 2007, two years after battery is attach to pcb assembly. When the unit was opened, the pcb and the battery appeared in good condition with no damage or sign of deterioration. There was no current measured from the enclosed battery; however, the unit is now expired as stated in the dhr and no current or voltage is to be expected. The allegations of the reported incident are not verified.
Patient Sequence No: 1, Text Type: N, H10
[19419008]
It was reported that an internal bone growth stimulator was implanted on an unknown date. Subsequently, patient reports that alleged defect in the leads did not allow proper bone growth stimulation from the unit. As a result, the patient alleged lower back pain and a procedure to remove the internal bone growth stimulator was performed on an unknown date. This report is based on allegations set forth in plaintiff's complaint, and the allegations contained therein are unverified.
Patient Sequence No: 1, Text Type: D, B5
[19476275]
Current information is insufficient to permit a conclusion as to the cause of the event. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0002242816-2013-00024 |
| MDR Report Key | 3029458 |
| Report Source | 00,04 |
| Date Received | 2013-04-01 |
| Date of Report | 2013-03-06 |
| Date Mfgr Received | 2013-03-06 |
| Device Manufacturer Date | 2012-06-12 |
| Date Added to Maude | 2013-04-01 |
| 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 | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. DAVID TALISH |
| Manufacturer Street | 100 INTERPACE PARKWAY |
| 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 | 2013-04-01 |
| Returned To Mfg | 2013-03-06 |
| Model Number | N/A |
| Catalog Number | 10-1398M |
| Lot Number | N/A |
| ID Number | N/A |
| Device Expiration Date | 2014-04-17 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EBI, LLC. |
| Manufacturer Address | 100 INTERPACE PARKWAY PARSIPPANY NJ 07054 US 07054 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2013-04-01 |