MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-26 for OSTEOGEN-20/M SURGICALLY IMPLANTED BONE GROWTH STIMULATOR N/A 10-1320M manufactured by Ebi, Llc..
[139957759]
(b)(4). The device will not be returned for analysis; however, and investigation of the reported event is in progress. Once the investigation is completed, a supplemental medwatch 3500a will be submitted. Concomitant medical products - zimmer natural system long blue 130 degree ccd angle. Right. 11. 5 mm x 40 cm. Zimmer natural system set screw. 8 mm diameter 3. 5 mm hex head. Bone graft- lifenet health. Morphogenic protein 2 (infuse) - medtronic. Therapy date: (b)(6) 2017. Device was not returned.
Patient Sequence No: 1, Text Type: N, H10
[139957760]
It was reported that the patient underwent a two stage revision due to infection. The first revision surgery was for placement of the bone stimulator due to atrophic non-union. The subsequent revision surgery occurred 6 months later, for the removal of the bone stimulator, and placement of antibiotic impregnated stem and bead due to infection. No additional patient consequences were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002242816-2019-00007 |
| MDR Report Key | 8453439 |
| Date Received | 2019-03-26 |
| Date of Report | 2019-06-18 |
| Date of Event | 2017-08-21 |
| Date Mfgr Received | 2019-05-30 |
| Date Added to Maude | 2019-03-26 |
| 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 | 0 |
| Brand Name | OSTEOGEN-20/M SURGICALLY IMPLANTED BONE GROWTH STIMULATOR |
| Generic Name | OSTEOGEN-20/M, BONE STIMULATOR |
| Product Code | LOE |
| Date Received | 2019-03-26 |
| Model Number | N/A |
| Catalog Number | 10-1320M |
| Lot Number | N/A |
| Device Expiration Date | 2017-06-04 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | EBI, LLC. |
| Manufacturer Address | 399 JEFFERSON ROAD PARSIPPANY NJ 07054 US 07054 |
| Brand Name | OSTEOGEN-20/M SURGICALLY IMPLANTED BONE GROWTH STIMULATOR |
| Generic Name | OSTEOGEN-20/M, BONE STIMULATOR |
| Product Code | LOE |
| Date Received | 2019-03-26 |
| Model Number | N/A |
| Catalog Number | 10-1320M |
| Lot Number | N/A |
| Device Expiration Date | 2017-06-04 |
| 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 | 2019-03-26 |