MAUDE Adverse Event Report: MEDTRONIC XOMED INC. UNIVERSAL TITANIUM PROSTHESIS; REPLACEMENT, OSSICULAR PROSTHESIS, TOTAL

Model Number 1150001

Device Problems Entrapment of Device (1212); Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/29/2014

Event Type  Injury  

Event Description

It was reported that a ¿universal titanium prosthesis, cam head, with flex h/a titanium shoe broke while being implanted in the patients ear.A small metal piece was lost in the middle ear and the doctor was unable to visualize it and said, ¿i cannot find it and if i go digging around i can cause more damage.¿ so the decision was made not to retrieve it.¿.

Manufacturer Narrative

This device is used for therapeutic purposes.Note: we were notified of this event when we received a copy of the facility¿s voluntary medwatch form on december 3, 2014.(b)(4): product evaluation: analysis could not be performed; device remains in patient¿s ear and will not be returned for evaluation.(b)(4).

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: UNIVERSAL TITANIUM PROSTHESIS
• Type of Device: REPLACEMENT, OSSICULAR PROSTHESIS, TOTAL
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr north; jacksonville FL 32216
• Manufacturer (Section G): MEDTRONIC XOMED, INC.; 6743 southpoint drive north; jacksonville FL 32216
• Manufacturer Contact: michelle alford ; 6743 southpoint drive north; jacksonville, FL 32216 ; 9043328197
• MDR Report Key: 4338383
• MDR Text Key: 19358472
• Report Number: 1045254-2014-00330
• Device Sequence Number: 1
• Product Code: ETA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K002897
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,health professional,use
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/11/2021
• Device Model Number: 1150001
• Device Catalogue Number: 1150001
• Device Lot Number: 0207296386
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/03/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/13/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 00023 YR
• Patient Weight: 50