MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-03-04 for UNKNOWN N/A manufactured by Ebi, Llc..
[137742313]
(b)(4). Date of event: the date of the adverse event was not reported by the patient. The device will not be returned for analysis as it is still implanted in the patient. A supplemental medwatch 3500a will be submitted when additional information is received. Device not returned to manufacturer
Patient Sequence No: 1, Text Type: N, H10
[137742314]
It was reported that the patient stated that she was experiencing pain and bone non-union/ mal-union from the spine implantable stimulator. Patient stated that she needs a new surgery but has not been able to communicate with her previous surgeon. She provided no further information and stated that she will contact her attorney.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002242816-2019-00006 |
| MDR Report Key | 8386952 |
| Report Source | CONSUMER |
| Date Received | 2019-03-04 |
| Date of Report | 2019-03-01 |
| Date Mfgr Received | 2019-02-27 |
| Date Added to Maude | 2019-03-04 |
| 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 | SHAAN POLIUS |
| 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 | UNKNOWN |
| Generic Name | SPINE FUSION STIMULATOR (SPF) |
| Product Code | LOE |
| Date Received | 2019-03-04 |
| Model Number | N/A |
| Catalog Number | UNK |
| Lot Number | N/A |
| Operator | LAY USER/PATIENT |
| 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 | 2019-03-04 |