MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other report with the FDA on 2016-05-24 for OGEN MESH CATHRODE/DETACHABLE N/A 10-1320M manufactured by Zimmer Biomet Spine - Broomfield.
[45819649]
The device evaluation is anticipated, a follow up report will be sent upon completion of the product evaluation.
Patient Sequence No: 1, Text Type: N, H10
[45819650]
The facility lab reported patient had bone stimulator explanted due to infection. Patient previously had wound complications from right ankle arthrodesis. She has a 3 year(s) history of right ankle pain and wound healing problems including infection for right ankle arthrodesis. Initial implant surgery performed on (b)(6) 2012. Patient developed infection in wound and chronic draining. Bone stimulator explanted on (b)(6) 2016. After explant, patient given antibiotics and had complex repair of stimulator cavity wound.
Patient Sequence No: 1, Text Type: D, B5
[47239333]
The unit and cable were received inside biohazard bag. A visual inspection of the returned device identified the unit cathode is broken. The device history records and sterilization records were reviewed and no anomalies were identified. It is reported the unit was implanted on (b)(6) 2012 and the implant stimulator should deliver its full rated current for approximately twenty-four (24) weeks; therefore the unit completed treatment two years ago. No physical and/or functional condition could be found that could be considered as causal factor for the reported complaint. The reported claim is most likely due to the clinical condition of the patient.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004485144-2016-00087 |
| MDR Report Key | 5676571 |
| Report Source | HEALTH PROFESSIONAL,OTHER |
| Date Received | 2016-05-24 |
| Date of Report | 2016-04-26 |
| Date of Event | 2016-03-23 |
| Date Mfgr Received | 2016-05-27 |
| Device Manufacturer Date | 2012-07-18 |
| Date Added to Maude | 2016-05-24 |
| 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 | 310 INTERLOCKEN PARKWAY SUITE 120 |
| Manufacturer City | BROOMFIELD CO 80021 |
| Manufacturer Country | US |
| Manufacturer Postal | 80021 |
| Manufacturer Phone | 3034437500 |
| Manufacturer G1 | ZIMMER BIOMET SPINE - BROOMFIELD |
| Manufacturer Street | 310 INTERLOCKEN PARKWAY SUITE 120 |
| Manufacturer City | BROOMFIELD CO 80021 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80021 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OGEN MESH CATHRODE/DETACHABLE |
| Generic Name | IMPLANTABLE BONE STIMULATOR |
| Product Code | LOE |
| Date Received | 2016-05-24 |
| Returned To Mfg | 2016-04-26 |
| Model Number | N/A |
| Catalog Number | 10-1320M |
| Lot Number | 540-12 |
| ID Number | N/A |
| Device Expiration Date | 2014-04-02 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER BIOMET SPINE - BROOMFIELD |
| Manufacturer Address | 310 INTERLOCKEN PARKWAY SUITE 120 BROOMFIELD CO 80021 US 80021 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2016-05-24 |