MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2016-09-21 for OSTEOGEN BONE GROWTH STIMULATOR N/A 10-1320 manufactured by Ebi, Llc..
[55273692]
Review of device history records show the lot released with no recorded anomaly or deviation. Without a product return, no product evaluation is able to be conducted. Current information is insufficient to permit a valid conclusion about the cause of this event. If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.
Patient Sequence No: 1, Text Type: N, H10
[55273693]
It was reported during a hip core decompression the bone stimulator was placed into the patient's body. The surgeon was attempting to place the lead where he wanted it when the wire broke off rendering the implant useless. The surgery was completed without using a bone growth stimulator.
Patient Sequence No: 1, Text Type: D, B5
[58205081]
The product was returned for evaluation. The product identity was confirmed through the visual inspection. Based on the evaluation, the product was returned in a plastic bag with the unit cathode broken. The device was tested and found to operate as intended despite the break. The most-likely root cause for the broken titanium wire was determined to be caused by the physician who caused fatigue on the wire until it broke. The cause of the event was determined to be not related to the manufacturing process.
Patient Sequence No: 1, Text Type: N, H10
[71630410]
The titanium wire was sent for further analysis by zimmer biomet warsaw research lab. The analysis confirms the most-likely cause of the titanium wire fracture was overload as the three wires showed ductile overload dimples. The most-likely cause for the overload was determined to be abrupt use by the physician during surgery.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0002242816-2016-00026 |
| MDR Report Key | 5967178 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-09-21 |
| Date of Report | 2016-08-23 |
| Date of Event | 2016-05-12 |
| Date Mfgr Received | 2017-02-28 |
| Device Manufacturer Date | 2015-09-03 |
| Date Added to Maude | 2016-09-21 |
| 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 | MRS. MICHELLE COLE |
| Manufacturer Street | 399 JEFFERSON ROAD |
| Manufacturer City | PARSIPPANY NJ 07054 |
| Manufacturer Country | US |
| Manufacturer Postal | 07054 |
| 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 | OSTEOGEN BONE GROWTH STIMULATOR |
| Generic Name | STIMULATOR, INVASIVE BONE GROWTH |
| Product Code | LOE |
| Date Received | 2016-09-21 |
| Returned To Mfg | 2016-10-11 |
| Model Number | N/A |
| Catalog Number | 10-1320 |
| Lot Number | 565-15 |
| ID Number | N/A |
| Device Expiration Date | 2016-12-29 |
| Operator | HEALTH PROFESSIONAL |
| 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. Other | 2016-09-21 |