MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-06-21 for OSTEOGEN-40/M N/A 10-1348M manufactured by Ebi, Llc..
[111863664]
(b)(4). Concomitant medical products: manufacturer: (b)(4), implant names: vitose bb. Trauma bone graft, modeucat no: 2102-2210, lot no: b1610024; vitoss bb trauma bone graft, modeucat no: 2102-2205. Lot no: b1610018; 7. 0 x 90 headless cannulated screw. Modeucat no: 658390 (1); 5. 0 x 50 headless screw. Model/cat no: 658150 (2): 4. 0 x 60 cannulated screw, modeucat no: 604660 (1); 4. 0 x 55 cannulated screw, modeucat no: 604655 (1). Therapy date: (b)(6) 2018. Customer has indicated that the product will not be returned to zimmer biomet for investigation. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Mw5075759.
Patient Sequence No: 1, Text Type: N, H10
[111863665]
Report number mw5075759 was received which states "patient, original ankle surgery (b)(6) 2017 with a zimmer bone stimulator implanted with additional implants. Reportedly patient has had problems with his ankle after the surgery on (b)(6) 2017, and was scheduled for revision surgery on (b)(6) 2017. Subsequently, physician received a recall letter related to the zimmer bone stimulator item# 10-1348m, lot# 521203. Item description: ogen dual mesh cathodes. " no additional patient consequences were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002242816-2018-00021 |
| MDR Report Key | 7624822 |
| Report Source | USER FACILITY |
| Date Received | 2018-06-21 |
| Date of Report | 2018-08-09 |
| Date of Event | 2018-02-27 |
| Date Mfgr Received | 2018-07-11 |
| Device Manufacturer Date | 2015-06-24 |
| Date Added to Maude | 2018-06-21 |
| 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 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OSTEOGEN-40/M |
| Generic Name | STIMULATOR, INVASIVE BONE GROWTH |
| Product Code | LOE |
| Date Received | 2018-06-21 |
| Model Number | N/A |
| Catalog Number | 10-1348M |
| Lot Number | 521203 |
| ID Number | (01) 0 0812301 02010 2 |
| Device Expiration Date | 2017-06-24 |
| Operator | PHYSICIAN |
| 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 | 2018-06-21 |