MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-03 for SPINALPAK ASSEMBLY N/A 1067716 manufactured by Ebi, Llc..
[188139465]
(b)(4). Date of event: the event occurred sometime in (b)(6) 2020. Concomitant medical product: nuvasive cohere porous peek interbody device x2; medical product: nuvasive archon titanium plate and screws; therapy date: (b)(6) 2020. The 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
[188139466]
It was reported that the patient developed hives from using the spinalpak assembly. The patient started to wear the unit and after two days she noticed her head became very itchy. The patient's neck started to get swollen and she was unable to breathe. The patient was wearing a neck brace and when she took it off she noticed that she had developed hives all over her head and body. The patient went to her medical doctor and was given a shot. The patient was sent home with prescribed medications. The patient has discontinued use of the spinalpak assembly. The patient stated that she experienced the same reaction with other stimulator devices before. No additional patient consequences have been reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002242816-2020-00026 |
| MDR Report Key | 9782424 |
| Report Source | CONSUMER |
| Date Received | 2020-03-03 |
| Date of Report | 2020-03-03 |
| Date Mfgr Received | 2020-02-17 |
| Date Added to Maude | 2020-03-03 |
| 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 | BONE GROWTH, STIMULATOR, NON-INVASIVE |
| Product Code | LOF |
| Date Received | 2020-03-03 |
| Model Number | N/A |
| Catalog Number | 1067716 |
| 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 | 2020-03-03 |