MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-07-06 for SPF SPINAL FUSION STIMULATOR N/A 10-1335M manufactured by Ebi, Llc..
[79229095]
(b)(4). It is reported the device was discarded, therefore no product will be returned to the manufacturer. Based on the information provided the device was removed as a precautionary measure. If additional information is obtained that adds value to the relevant content of this report a follow-up report will be sent.
Patient Sequence No: 1, Text Type: N, H10
[79229096]
It was reported when the patient came back into the office on (b)(6) 2017 the surgeon removed the spf device as a precautionary measure due to the receipt of a recall notice (zfa 2017-245). The battery and leads were explanted and disposed of.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002242816-2017-00026 |
| MDR Report Key | 6690971 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-07-06 |
| Date of Report | 2017-07-06 |
| Date of Event | 2017-06-01 |
| Date Mfgr Received | 2017-06-06 |
| Device Manufacturer Date | 2016-10-27 |
| Date Added to Maude | 2017-07-06 |
| 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 | ZFA 2017-245 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPF SPINAL FUSION STIMULATOR |
| Generic Name | IMPLANTABLE STIMULATOR; SPF-XL IIB 2/DM |
| Product Code | LOE |
| Date Received | 2017-07-06 |
| Model Number | N/A |
| Catalog Number | 10-1335M |
| Lot Number | 585-17 |
| ID Number | SEE H10 NARRATIVE |
| Device Expiration Date | 2018-10-27 |
| 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. Hospitalization; 2. Required No Informationntervention | 2017-07-06 |