MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2017-03-29 for EBI SPF IMPLANTABLE SPINAL FUSION STIMULATOR N/A 10-1335M manufactured by Ebi, Llc..
[71164281]
Because the part and lot numbers are unknown, the device history records could not be pulled and reviewed. Without a product return, no product evaluation is able to be conducted. 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
[71164282]
The distributor reported the surgeon explanted the device because the patient said he was experiencing pain at the location of the battery. More information was requested and has yet to be received.
Patient Sequence No: 1, Text Type: D, B5
[74388321]
(b)(4). Review of device history records show the lot released with no recorded anomaly or deviation. 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
[74388322]
Additional information was received from the sales representative. The product was implanted on (b)(6) 2016 and explanted on (b)(6) 2017. It is reported that there was no injury after implantation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002242816-2017-00010 |
| MDR Report Key | 6442373 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2017-03-29 |
| Date of Report | 2017-03-29 |
| Date Mfgr Received | 2017-04-04 |
| Device Manufacturer Date | 2016-04-18 |
| Date Added to Maude | 2017-03-29 |
| 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-XL IIB 2/DM |
| Product Code | LOE |
| Date Received | 2017-03-29 |
| Model Number | N/A |
| Catalog Number | 10-1335M |
| Lot Number | UNKNOWN |
| ID Number | SEE H10 NARRATIVE |
| Device Expiration Date | 2018-04-18 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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. Hospitalization; 2. Required No Informationntervention | 2017-03-29 |