MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-01-24 for SPINALPAK STIMULATOR, BIOMET N/A 1067717 manufactured by Ebi, Llc..
[188861482]
Zimmer biomet complaint (b)(4). Date of event: the event occurred sometime in (b)(6) 2020. The customer has indicated that the product will not be returned to zimmer biomet for investigation because the patient is still using the product. The investigation is in process. Once the investigation has been completed, a follow up mdr will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0002242816-2020-00012 and 0002242816-2020-00013. The device was not returned.
Patient Sequence No: 1, Text Type: N, H10
[188861503]
It was reported that the patient was experiencing pain from the spinalpak stimulator. The patient was using the spinalpak stimulator with the lt-4500 and 72r electrodes. The patient stated that the pain was on the right side of her back in the kidney area and across the hip. The patient stated that the pain is below the skin and the pain level is a 10, on a scale of 1-10. The patient stopped using the stimulator and the pain did not go away. The patient called their doctor and was prescribed ibuprofen and advised not to use the stimulator for a week. The patient believes that the pain was from the inflammation of the incision. No additional patient consequences have been reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002242816-2020-00014 |
| MDR Report Key | 9627139 |
| Report Source | CONSUMER |
| Date Received | 2020-01-24 |
| Date of Report | 2020-01-24 |
| Date Mfgr Received | 2020-01-08 |
| Date Added to Maude | 2020-01-24 |
| 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 | SARA DAILEY |
| 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 | SPINALPAK STIMULATOR, BIOMET |
| Generic Name | STIMULATOR, BONE GROWTH, NON-INVASIVE |
| Product Code | LOF |
| Date Received | 2020-01-24 |
| Model Number | N/A |
| Catalog Number | 1067717 |
| Lot Number | UNK |
| 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 | 2020-01-24 |