MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-01 for BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATOR SYSTEM N/A 1067716 manufactured by Ebi, Llc..
[143806416]
Zimmer biomet : (b)(4). Date of event: the event occurred sometime in march 2019. 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
[143806497]
It was reported that the patient experienced nerve pain from using the spinal pak. The patient stated that 3 or 4 days after using the device, he started experiencing symptoms of pain and tingling in his quad. He was advised by his doctor to discontinue use of the spinal pak, because according to his doctor the swelling in his femoral nerve was due to the spinal pak. No additional patient consequences were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002242816-2019-00010 |
| MDR Report Key | 8571387 |
| Date Received | 2019-05-01 |
| Date of Report | 2019-08-14 |
| Date Mfgr Received | 2019-07-26 |
| Device Manufacturer Date | 2019-02-06 |
| Date Added to Maude | 2019-05-01 |
| 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 | 0 |
| Brand Name | BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATOR SYSTEM |
| Generic Name | SPINAK PAK ASSEMBLY |
| Product Code | LOF |
| Date Received | 2019-05-01 |
| Returned To Mfg | 2019-06-01 |
| Model Number | N/A |
| Catalog Number | 1067716 |
| Lot Number | N/A |
| Operator | LAY USER/PATIENT |
| 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 | 1. Required No Informationntervention | 2019-05-01 |