MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-12-12 for ORTHOPAK ASSEMBLY N/A 1067718 manufactured by Ebi, Llc..
[185803645]
(b)(4). Date of event: the event occurred sometime in (b)(6) 2019. Concomitant medical product: left femur trochanteric fixation nail concomitant medical products: therapy date: (b)(6) 2019. The customer has indicated that the product is in process of being returned to zimmer biomet for investigation. Once the investigation has been complete, a follow-up mdr will be submitted. The device has not been returned.
Patient Sequence No: 1, Text Type: N, H10
[185803646]
It was reported that the patient was experiencing pain and discomfort from the orthopak assembly. The patient stated that she is very uncomfortable due to the placement of the unit. Her injury is very high on her femur so the unit gets in the way of her everyday activities. The patient stated that her pain is more intense when using the orthopak. The patient did reach out to her doctor and sales representative and the patient was switched to a different device for treatment. No additional patient consequences were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002242816-2019-00048 |
| MDR Report Key | 9459953 |
| Report Source | CONSUMER |
| Date Received | 2019-12-12 |
| Date of Report | 2020-03-13 |
| Date Mfgr Received | 2020-03-06 |
| Device Manufacturer Date | 2019-11-06 |
| Date Added to Maude | 2019-12-12 |
| 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 | ORTHOPAK ASSEMBLY |
| Generic Name | STIMULATOR, BONE GROWTH, NON-INVASIVE |
| Product Code | LOF |
| Date Received | 2019-12-12 |
| Returned To Mfg | 2020-03-03 |
| Model Number | N/A |
| Catalog Number | 1067718 |
| 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 | 2019-12-12 |