MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-01-14 for BIOMET EBI BONE HEALING SYSTEM N/A 1068234 manufactured by Ebi, Llc..
[186844111]
(b)(4). Date of event: the event occurred sometime in (b)(6) 2019. Concomitant medical product: left hip cephalomedullary nail. 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.
Patient Sequence No: 1, Text Type: N, H10
[186844112]
It was reported that the patient was experiencing pain from using the bone healing system (bhs). The patient got the bhs for her left femur. The patient stated that she experienced a throbbing pain in her right frontal lobe. After thirty minutes, the throbbing was in her cheekbone and then went down her left leg. The patient reached out to her doctor and was advised to break up her treatment time into 4 hour increments. The patient was not able to wear the unit for four hours straight due to the pain. The patient uses the bhs for a couple hours each day. The doctor provided a script to switch the patient to a different device for treatment. No additional patient consequences were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002242816-2020-00007 |
| MDR Report Key | 9588410 |
| Report Source | CONSUMER |
| Date Received | 2020-01-14 |
| Date of Report | 2020-01-14 |
| Date Mfgr Received | 2019-12-31 |
| Date Added to Maude | 2020-01-14 |
| 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 | 2020-01-14 |
| Model Number | N/A |
| Catalog Number | 1068234 |
| 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 | 2020-01-14 |