MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-12-03 for BIOMET EBI BONE HEALING SYSTEM N/A 1068234 manufactured by Ebi, Llc..
[168785551]
(b)(4). Date of event: the event occurred sometime in (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. Device has not been returned.
Patient Sequence No: 1, Text Type: N, H10
[168785552]
It was reported that the patient experienced pain from using the bone healing system. The patient was using the device for a tibial fracture nonunion and was experiencing pain in his foot. The patient used the unit for one day. The patient saw his physician and was advised to stop using the unit. No additional patient consequences were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002242816-2019-00041 |
| MDR Report Key | 9401021 |
| Report Source | CONSUMER |
| Date Received | 2019-12-03 |
| Date of Report | 2020-03-27 |
| Date Mfgr Received | 2020-03-18 |
| Device Manufacturer Date | 2019-05-01 |
| Date Added to Maude | 2019-12-03 |
| 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 | BIOMET EBI BONE HEALING SYSTEM |
| Generic Name | STIMULATOR, BONE GROWTH, NON-INVASIVE |
| Product Code | LOF |
| Date Received | 2019-12-03 |
| Model Number | N/A |
| Catalog Number | 1068234 |
| Lot Number | N/A |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| 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 | 2019-12-03 |