MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-12-16 for SPINALPAK ASSEMBLY N/A 1067716 manufactured by Ebi, Llc..
[187615699]
(b)(4). Date of event: the event occurred sometime in (b)(6) 2019. Concomitant medical product: stryker pedicle screws - l3, l4. Therapy date: (b)(6) 2019. Medical product: bilateral rods. Therapy date: (b)(6) 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
[187615701]
It was reported that the patient was experiencing severe pain from the spinalpak assembly. The patient stated that she used the unit for 8 hours and the following day she experienced pain in her right hip, lumbar region, and right leg. The patient stated that the pain feels like irritated nerves and it is below the skin. The patient is taking pain medication from her surgery but it takes a long time to take effect. The patient tried to wear the spinalpak unit the next day and the pain began again. The patient spoke to the physician's assistant at her doctor's office and was advised to stop using the unit. No additional patient consequences have been reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002242816-2019-00052 |
| MDR Report Key | 9475529 |
| Report Source | CONSUMER |
| Date Received | 2019-12-16 |
| Date of Report | 2020-03-13 |
| Date Mfgr Received | 2020-03-11 |
| Device Manufacturer Date | 2019-11-22 |
| Date Added to Maude | 2019-12-16 |
| 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 ASSEMBLY |
| Generic Name | STIMULATOR, BONE GROWTH, NON-INVASIVE |
| Product Code | LOF |
| Date Received | 2019-12-16 |
| Returned To Mfg | 2020-03-09 |
| 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 | 2019-12-16 |