MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-05-03 for PROSTHESIS - POLYCEL 1156363 manufactured by Medtronic Xomed Inc..
[143960579]
Analysis found that there was a residue consistent with biological contaminants on the device. Visually, the device was consistent with being bent until broken which would have resulted in the reported event. The two portions returned measured 0. 161? And 0. 118? Long for a total length of 0. 279?. The overall length shall measure 0. 275? /+-0. 010? Therefore the information most likely indicates all portions of the device were returned. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[143960580]
A health care provider (hcp) reported via a manufacturer representative that the prosthesis broke off and detached during an ossicular reconstruction procedure without excess force. The prosthesis was operated with an alligator forceps. This was the first time the device was used. There was no intervention planned and performed. There was a delay of about 5-8 minutes. There was no broken pieces left/remained inside the patient's body. The procedure was completed with back up device. There was no patient impact.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1045254-2019-00225 |
| MDR Report Key | 8577647 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-05-03 |
| Date of Report | 2019-05-03 |
| Date of Event | 2019-03-27 |
| Date Mfgr Received | 2019-04-07 |
| Device Manufacturer Date | 2015-10-19 |
| Date Added to Maude | 2019-05-03 |
| 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 | CHRISTY CAIN |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9043328353 |
| Manufacturer G1 | MEDTRONIC XOMED INC. |
| Manufacturer Street | 6743 SOUTHPOINT DR N |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32216 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROSTHESIS - POLYCEL |
| Generic Name | REPLACEMENT, OSSICULAR PROSTHESIS, TOTAL |
| Product Code | ETA |
| Date Received | 2019-05-03 |
| Returned To Mfg | 2019-04-12 |
| Model Number | 1156363 |
| Catalog Number | 1156363 |
| Lot Number | 0210298025 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC XOMED INC. |
| Manufacturer Address | 6743 SOUTHPOINT DR N JACKSONVILLE FL 32216 US 32216 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-03 |