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 2017-12-13 for SPF-XL IIB 2/DW N/A 10-1335W manufactured by Ebi, Llc..
[95081481]
(b)(4). Customer has indicated that the product is in process of being returned to zimmer biomet for investigation. Once the investigation has been completed, a follow-up mdr will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[95081482]
It was reported that the surgeon was operating for revision lumbar pseudoarthrosis to replace hardware and bone grafting, t9 to s1 medtronic hardware and biologics bone grafting, the implantable stimulator did not test positive for implantation and there was not a backup stimulator. Specifically, the test light failed to light up. The stimulator was not used. No adverse events have been reported as a result of the malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002242816-2017-00052 |
| MDR Report Key | 7114318 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2017-12-13 |
| Date of Report | 2018-01-11 |
| Date of Event | 2017-11-16 |
| Date Mfgr Received | 2017-12-18 |
| Device Manufacturer Date | 2016-07-15 |
| Date Added to Maude | 2017-12-13 |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPF-XL IIB 2/DW |
| Generic Name | STIMULATOR, INVASIVE BONE GROWTH |
| Product Code | LOE |
| Date Received | 2017-12-13 |
| Returned To Mfg | 2017-12-15 |
| Model Number | N/A |
| Catalog Number | 10-1335W |
| Lot Number | 224094 |
| ID Number | SEE H10 NARRATIVE |
| Device Expiration Date | 2018-07-15 |
| Operator | PHYSICIAN |
| 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 | 399 JEFFERSON ROAD PARSIPPANY NJ 07054 US 07054 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-12-13 |