MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-24 for PROSTHESIS - POLYCEL 1156363 manufactured by Medtronic Xomed Inc..
[143057528]
Analysis found that the device shaft was broken. The two portions returned measured 0. 121? And 0. 134? Long for a total length of 0. 255?. The overall length shall measure 0. 275? /+-0. 010". There was a residue consistent with biological contaminants on the device. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[143057529]
A health care provider (hcp) via a distributor reported that a prosthesis broke into two pieces during ossicular reconstruction surgery. The hcp made sure that no fragments remained inside the patient's body and noted that the device was handled gently without improper force. The procedure was completed using a back-up product. There was a procedure delay of 10 minutes. There was no patient impact.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1045254-2019-00210 |
| MDR Report Key | 8547537 |
| Date Received | 2019-04-24 |
| Date of Report | 2019-04-24 |
| Date of Event | 2019-03-25 |
| Date Mfgr Received | 2019-03-29 |
| Date Added to Maude | 2019-04-24 |
| 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 | 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 | 0 |
| Brand Name | PROSTHESIS - POLYCEL |
| Generic Name | REPLACEMENT, OSSICULAR PROSTHESIS, TOTAL |
| Product Code | ETA |
| Date Received | 2019-04-24 |
| Returned To Mfg | 2019-04-12 |
| Model Number | 1156363 |
| Catalog Number | 1156363 |
| Lot Number | 0205886574 |
| 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 | 2019-04-24 |