MAUDE Adverse Event Report: HEINZ KURZ GMBH MEDIZINTECHNIK KURZ LENTICLE CUP PROSTHETICS; PROSTHESIS, PARTIAL OSSICULAR REPLACEMENT

Catalog Number REF #1006525

Device Problem Temperature Problem (3022)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

Patient presented for mri with bilateral kurz lenticle cup prosthetics- ref# (b)(4).Patient complained that left side heated up.Literature and manufacturer documentation discloses it is mri conditional and safe on a 1.5t up to a 7t strength magnet.Fda safety report id # (b)(4).

• Brand Name: KURZ LENTICLE CUP PROSTHETICS
• Type of Device: PROSTHESIS, PARTIAL OSSICULAR REPLACEMENT
• Manufacturer (Section D): HEINZ KURZ GMBH MEDIZINTECHNIK
• MDR Report Key: 11055944
• MDR Text Key: 223458280
• Report Number: MW5098484
• Device Sequence Number: 1
• Product Code: ETB
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: REF #1006525
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1