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 2018-03-27 for OSTEOGEN-20/M N/A 10-1320M manufactured by Ebi, Llc..
[103603342]
(b)(4). 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.
Patient Sequence No: 1, Text Type: N, H10
[103603343]
It was reported a revision was performed to remove the device due to irritation, pain, and inflammatory response. "the patient could feel device through skin causing pain. " no additional patient consequences were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0002242816-2018-00006 |
| MDR Report Key | 7374915 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-03-27 |
| Date of Report | 2018-05-23 |
| Date of Event | 2018-03-01 |
| Date Mfgr Received | 2018-04-27 |
| Device Manufacturer Date | 2016-07-27 |
| Date Added to Maude | 2018-03-27 |
| 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-20/M |
| Generic Name | STIMULATOR, INVASIVE BONE GROWTH |
| Product Code | LOE |
| Date Received | 2018-03-27 |
| Model Number | N/A |
| Catalog Number | 10-1320M |
| Lot Number | N/A |
| ID Number | (01)0 0812301 02003 4 |
| Device Expiration Date | 2018-07-27 |
| 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. Hospitalization; 2. Required No Informationntervention | 2018-03-27 |