MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-25 for PROSTHESIS - STAPES 1156604 manufactured by Medtronic Xomed Inc..
[32251113]
This device is used for therapeutic purposes. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[32251114]
It was reported that the doctor "was placing the prosthesis and crimping the loop, the shaft broke up. It had to be extracted from middle ear and replaced by another prosthesis of the same model. �here was no patient injury reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[35240235]
On 12/07/2015: the device was received for evaluation. Condition upon receipt: 1 un-sealed sample, part number 1156604, from lot number 0208063417. Equipment used: microscope (zeiss stemi 2000c between 0, 65 to 5, 0 magnification settings). Evaluation: when compared to the assembly drawing 63d3014 revision d: visually, there was a break point just proximal to the hook which would have resulted in the reported event. When viewed under magnification, there were tool marks on both sides of the break and the shaft was bent. A review of the last 2 years of complaint data showed no other similar reports against this part number. The complaint was confirmed for the alleged malfunction [shaft broke while crimping the loop]. Based on the available evidence and information the most likely underlying cause is consistent with mishandling. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[102478365]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1045254-2015-00389 |
| MDR Report Key | 5250512 |
| Date Received | 2015-11-25 |
| Date of Report | 2015-10-29 |
| Date of Event | 2015-10-28 |
| Date Mfgr Received | 2015-12-10 |
| Device Manufacturer Date | 2014-02-20 |
| Date Added to Maude | 2015-11-25 |
| 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 | CHARLOTTE AYALA |
| Manufacturer Street | 6743 SOUTHPOINT DR N |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9043328372 |
| Manufacturer G1 | MEDTRONIC, 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 - STAPES |
| Generic Name | REPLACEMENT, OSSICULAR PROSTHESIS, TOTAL |
| Product Code | ETA |
| Date Received | 2015-11-25 |
| Returned To Mfg | 2015-12-07 |
| Model Number | 1156604 |
| Catalog Number | 1156604 |
| Lot Number | 0208063417 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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 | 2015-11-25 |