MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-10-22 for SOFT-TOUCH ELECTRODES, 63B N/A 106130-22 manufactured by Ebi, Llc..
[170791400]
(b)(4). Date of event: the event occurred sometime in (b)(6) 2019. Concomitant medical product: spinalpak assembly: catalog #1067716 serial #(b)(4). Therapy date: unknown. Medical product: l4-5 pedicle screws. Therapy date: (b)(6) 2019. The customer has indicated that the product is in the process of being returned to zimmer biomet for investigation. 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: 0002242816-2019-00033. Device has not been returned.
Patient Sequence No: 1, Text Type: N, H10
[170791401]
It was reported that the patient was experiencing numbness and pain through the legs and into the feet from using the 72r and 63b electrodes. The patient stated that she experienced numbness before using the spinalpak but it intensified once she started using the unit. The patient stated that the pain was in her nerves and the pain level was at a 10, with 10 being the worst. The patient spoke to the physician's assistant at the neurosurgeon's office who advised her to stop treatment for 4 days to see if there is any difference in numbness. The patient was called 4 days later and the patient reported that she resumed treatment because she experienced the same amount of numbness without using the spinalpak. No additional patient consequences were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002242816-2019-00034 |
| MDR Report Key | 9219670 |
| Report Source | CONSUMER |
| Date Received | 2019-10-22 |
| Date of Report | 2019-10-22 |
| Date Mfgr Received | 2019-10-10 |
| Date Added to Maude | 2019-10-22 |
| 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 | SOFT-TOUCH ELECTRODES, 63B |
| Generic Name | ELECTRODES |
| Product Code | LOF |
| Date Received | 2019-10-22 |
| Model Number | N/A |
| Catalog Number | 106130-22 |
| 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 | 2019-10-22 |