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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC XOMED INC. PROSTHESIS - STAPES; REPLACEMENT, OSSICULAR PROSTHESIS, TOTAL
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MEDTRONIC XOMED INC. PROSTHESIS - STAPES; REPLACEMENT, OSSICULAR PROSTHESIS, TOTAL Back to Search Results
Model Number 1156602
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/09/2022
Event Type  malfunction  
Event Description
A healthcare professional (hcp) reported that the piston broke whilst being crimped.The broken implant was retrieved and another one was implanted.The product had contact with the patient.It will not be returned as it was discarded by the customer.The reported event resulted in a procedure delay/extended time of 5 minutes.There was no patient impact.The procedure was completed with backup products.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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Brand Name
PROSTHESIS - STAPES
Type of Device
REPLACEMENT, OSSICULAR PROSTHESIS, TOTAL
Manufacturer (Section D)
MEDTRONIC XOMED INC.
6743 southpoint dr n
jacksonville FL 32216
Manufacturer (Section G)
MEDTRONIC XOMED INC.
6743 southpoint dr n
jacksonville FL 32216
Manufacturer Contact
glen belmer
6743 southpoint drive north
jacksonville, FL 32216
6122713209
MDR Report Key13786183
MDR Text Key287347689
Report Number1045254-2022-00140
Device Sequence Number1
Product Code ETA
UDI-Device Identifier00721902848209
UDI-Public00721902848209
Combination Product (y/n)N
Reporter Country CodeNZ
PMA/PMN Number
K002897
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 03/16/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/16/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number1156602
Device Catalogue Number1156602
Device Lot Number0213286447
Was Device Available for Evaluation? No
Date Manufacturer Received02/15/2022
Date Device Manufactured05/09/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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