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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: I.T.S. GMBH CLAVICLE PLATE 3.5MM, 8-HOLE

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I.T.S. GMBH CLAVICLE PLATE 3.5MM, 8-HOLE Back to Search Results
Model Number 21122-8
Device Problem Fracture (1260)
Patient Problem Insufficient Information (4580)
Event Date 11/08/2017
Event Type  malfunction  
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Type of DeviceCLAVICLE PLATE 3.5MM, 8-HOLE
Manufacturer (Section D)
autal 28
lassnitzh[?]he, styria 8301
AU 8301
Manufacturer (Section G)
autal 28
lassnitzh[?]he, styria 8301
AU 8301
Manufacturer Contact
florian grill
autal 28
lassnitzhoehe, 8301
AU   8301
MDR Report Key15121466
Report Number3004369035-2022-00010
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 07/28/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/28/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number21122-8
Device Catalogue Number21122-8
Device Lot Number679/041704
Was Device Available for Evaluation? No
Date Manufacturer Received07/20/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 07/28/2022 Patient Sequence Number: 1