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

Model Number XOM UNK PROSTHESIS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Failure of Implant (1924); Therapeutic Response, Decreased (2271)

Event Type  Injury  

Manufacturer Narrative

Product evaluation: analysis results are not available; device not returned for evaluation.*note: this article reports product extrusion and too short of an implant as reasons for revisions.Both of these reported reasons are being filed as separate mdr's, both with the same reference number, (b)(4).A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Results reported in the literature article ¿transcanal endoscopic ear surgery for middle ear cholesteatoma¿, glikson, e., et al, otology <(>&<)> neurotology, vol.38, no.Xx, 2017, indicate that out of 123 total ossicular chain reconstruction procedures, 3 patients required revisions due to too short prosthesis.The objective of the research: ¿ossicular chain disruption in children leads to conductive hearing loss.Few studies have focused on factors influencing successful results in pediatric ossicular chain reconstruction (ocr).We aim to determine whether demographic or surgical factors affect hearing outcomes in pediatric ocr.¿ the authors confirm that ¿all revision cases were completed to improve hearing outcomes.".

Manufacturer Narrative

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

Event Description

Correct title of journal article: ¿factors influencing hearing outcomes in pediatric patients undergoing ossicular chain reconstruction¿, n.Govil, et al.; international journal of pediatric otorhinolaryngology 99 (2017) 60-65.Http://dx.Doi.Org/10.1016/j.Ijporl.2017.05.022.

• Brand Name: 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 dr north; jacksonville FL 32216
• Manufacturer Contact: michelle alford ; 6743 southpoint drive north; jacksonville, FL 32216 ; 9043328197
• MDR Report Key: 6768071
• MDR Text Key: 81846758
• Report Number: 1045254-2017-00269
• Device Sequence Number: 1
• Product Code: ETA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,litera
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: XOM UNK PROSTHESIS
• Device Catalogue Number: XOM UNK PROSTHESIS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/17/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention