MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2017-09-21 for EBI SPF IMPLANTABLE SPINAL FUSION STIMULATOR N/A 10-1398M manufactured by Ebi, Llc..
[86983969]
(b)(4). Review of device history records show the lot released with no recorded anomaly or deviation. The device was discarded, therefore no device evaluation can be performed. Current information is insufficient to permit a valid conclusion about the cause of this event. If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.
Patient Sequence No: 1, Text Type: N, H10
[86983970]
It is reported the spf device failed before closing the patient during a lumbar fusion revision of non-zimmer biomet devices. The spf device was removed and nothing was implanted in its place. There was no delay in surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002242816-2017-00043 |
| MDR Report Key | 6882275 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2017-09-21 |
| Date of Report | 2017-09-21 |
| Date of Event | 2017-08-22 |
| Date Mfgr Received | 2017-08-25 |
| Device Manufacturer Date | 2016-06-27 |
| Date Added to Maude | 2017-09-21 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. MICHELLE COLE |
| Manufacturer Street | 399 JEFFERSON ROAD |
| Manufacturer City | PARSIPPANY NJ 07054 |
| Manufacturer Country | US |
| Manufacturer Postal | 07054 |
| Manufacturer Phone | 9732999300 |
| Manufacturer G1 | EBI, LLC. |
| Manufacturer Street | 399 JEFFERSON ROAD |
| Manufacturer City | PARSIPPANY NJ 07054 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07054 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EBI SPF IMPLANTABLE SPINAL FUSION STIMULATOR |
| Generic Name | STIMULATOR, INVASIVE BONE GROWTH, SPF-PLUS 60/M |
| Product Code | LOE |
| Date Received | 2017-09-21 |
| Model Number | N/A |
| Catalog Number | 10-1398M |
| Lot Number | 409718 |
| ID Number | SEE H10 NARRATIVE |
| Device Expiration Date | 2018-06-27 |
| 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 | 2017-09-21 |