MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-02-04 for BIOMET EBI BONE HEALING SYSTEM SFLX 1 COIL N/A 1068225 manufactured by Ebi, Llc..
[188861915]
Zimmer biomet complaint (b)(4). Date of event: the event occurred sometime in (b)(6) 2020. Medical product: screw in distal fibula, therapy date: (b)(6) 2019, medical product: biomet ebi bone healing system catalog: #1068234 serial: # (b)(4), therapy date: unknown. 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. The device has not been returned.
Patient Sequence No: 1, Text Type: N, H10
[188861916]
It was reported that the patient was experiencing symptoms from using the sflx 1 coil. The patient is using the sflx 1 coil on his left ankle. The patient stated that he can't use the device because he has nerve damage down the left leg and to the top of the foot. The sflx 1 coil is constantly rubbing on the patient's skin which makes it feel like a bad sunburn. The patient did contact his doctor and 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 | 0002242816-2020-00017 |
| MDR Report Key | 9664236 |
| Report Source | CONSUMER |
| Date Received | 2020-02-04 |
| Date of Report | 2020-02-03 |
| Date Mfgr Received | 2020-01-21 |
| Date Added to Maude | 2020-02-04 |
| 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 SFLX 1 COIL |
| Generic Name | STIMULATOR, BONE GROWTH, NON-INVASIVE (COIL) |
| Product Code | LOF |
| Date Received | 2020-02-04 |
| Model Number | N/A |
| Catalog Number | 1068225 |
| Lot Number | UNK |
| 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 | 2020-02-04 |