MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07 report with the FDA on 2015-01-16 for UNIVERSAL TITANIUM PROSTHESIS 1150000 manufactured by Medtronic Xomed Inc..
[18086636]
It was reported that? The patient complained that the hearing didn? T get improved after the implant, so the doctor decided to do second surgery. The doctor planned to take out the prosthesis and implant it later. However, during the procedure, the titanium part of the shoe detached from the white part of the shoe. The doctor spent about 20 minutes taking out the fragments of new prosthesis and opened another new prosthesis to complete the surgery. As a result, the operation was delayed for 20 minutes.?
Patient Sequence No: 1, Text Type: D, B5
[18535722]
Blank fields in this report are the result of information not provided by the initial reporter or user facility. This device is used for therapeutic purposes. (b)(4). The device was received and evaluated. As received condition: received 1 sample(s), part number 1150001, from lot number [not provided]; there was evidence of biological contaminants [based off of the reactivity with hydrogen peroxide]. Note: the reported part number was 1150000 and the shape and size of the returned sample indicates the part number is actually 1150001; the lot number 0208316321 is not valid for the reported part; the returned sample? Labeling? Is not consistent with the returned sample. Equipment used: microscope (zeiss stemi 2000c between 0, 65 to 5, 0 magnification settings), calipers. Observations: when compared to the assembly drawing: a break point occurred in the bell mounting area of the flex h/a [part cp070092] which would have resulted in the reported malfunction. The head of the prosthesis was bent which is an indicator that the device was mishandled. The titanium bell showed signs of a residue consistent with adhesive [part 60d1141] indicating that the flex h/a was attached at some point to the bell and it was assembled per the drawing; manufacturing has been ruled out as a potential cause. Note: a portion of the flex h/a was still attached to the shaft and was removed for further analysis. The shaft configuration at the end is consistent with it being trimmed. The overall length of the head/shaft assembly indicates a? Reference? Overall length of 0. 400 inch [10. 16mm] and the actual measurement was 0. 09?. The information indicates the device was modified. There were no signs that the device was closed in the lid of the capsule and there was no damage to the packaging / capsule. The h/a side where the break occurred was jagged which indicates it was pulled apart. There was no evidence of improper manufacturing; therefore, has been ruled out as a potential cause. Based on the above observations the underlying cause is consistent with, mishandling. Methods: microscopic inspection fda. Results: fracture problem fda.
Patient Sequence No: 1, Text Type: N, H10
[32242945]
Additional information was received that clarified the event. The implanted prosthesis broke during removal of the device; the second prosthesis did not break. For 0208316361 expiration date: 05/2022, 05/2014.
Patient Sequence No: 1, Text Type: N, H10
[32242946]
Additional information was received that clarified the event. The implanted prosthesis broke during removal of the device; the second prosthesis did not break.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 1045254-2015-00017 |
MDR Report Key | 4427428 |
Report Source | 01,05,06,07 |
Date Received | 2015-01-16 |
Date of Report | 2014-12-22 |
Date of Event | 2014-12-15 |
Date Mfgr Received | 2015-02-16 |
Device Manufacturer Date | 2014-05-01 |
Date Added to Maude | 2015-01-16 |
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 | 0 |
Event Location | 0 |
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 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 | UNIVERSAL TITANIUM PROSTHESIS |
Generic Name | REPLACEMENT, OSSICULAR PROSTHESIS, TOTAL |
Product Code | ETA |
Date Received | 2015-01-16 |
Returned To Mfg | 2014-12-23 |
Model Number | 1150000 |
Catalog Number | 1150000 |
Lot Number | 0208316361 |
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 | 1. Required No Informationntervention | 2015-01-16 |