MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-11-28 for EBI OSTEOGEN-20/M BONE GROWTH STIMULATORS N/A 10-1320M manufactured by Ebi, Llc..
[128652070]
The device will not be returned for analysis; however, an investigation of the reported event is in progress. Once the investigation is completed, a supplemental medwatch 3500a will be submitted. Device has not been returned.
Patient Sequence No: 1, Text Type: N, H10
[128652071]
It was reported that the patient experienced pain with the osteogen device. The patient is suffering from a degenerative bone disease and had the device implanted on (b)(6) 2017 as part of an ankle reconstruction. The patient claims to have been in pain since the surgery. Her doctor was running a test for infection, with a scheduled follow up appointment in the coming weeks. No known adverse event was reported. No additional patient consequences were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002242816-2018-00037 |
| MDR Report Key | 8112196 |
| Report Source | CONSUMER |
| Date Received | 2018-11-28 |
| Date of Report | 2018-11-19 |
| Date of Event | 2017-07-31 |
| Date Mfgr Received | 2018-11-07 |
| Date Added to Maude | 2018-11-28 |
| 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 | SHAAN POLIUS |
| 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 | EBI OSTEOGEN-20/M BONE GROWTH STIMULATORS |
| Generic Name | OSTEOGEN-20/M |
| Product Code | LOE |
| Date Received | 2018-11-28 |
| Model Number | N/A |
| Catalog Number | 10-1320M |
| Lot Number | N/A |
| Device Expiration Date | 2018-09-19 |
| 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 | 2018-11-28 |