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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: I.T.S. GMBH DISTAL FEMUR PLATE, 9-HOLE, LEFT

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I.T.S. GMBH DISTAL FEMUR PLATE, 9-HOLE, LEFT Back to Search Results
Model Number 21302-9
Device Problem Deformation Due to Compressive Stress (2889)
Patient Problem Insufficient Information (4580)
Event Date 03/25/2022
Event Type  Injury  
Manufacturer Narrative
As no lot no.Was provided, we have inspected the qc documents of three lots that were shipped to the distributor and the quality inspection forms as well as the material certificates showed no deviations and complies with the specifications.The quality forms met all dimensional and visual criteria at the time of release with no issues documented during the manufacturing that would contribute to this complaint condition.A review of the raw material device history record revealed no deviation.The material was determined to be conforming and was used as is per product development approval.If further information gets available, as supplemental report will be filed.
 
Event Description
It was reported that a distal femur plate 9-hole bent approx.2 months post-op.Device used for diagnosis not known.
 
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Brand Name
DISTAL FEMUR PLATE, 9-HOLE, LEFT
Type of Device
DISTAL FEMUR PLATE, 9-HOLE, LEFT
Manufacturer (Section D)
I.T.S. GMBH
autal 28
lassnitzh[?]he, styria 8301
AU  8301
Manufacturer (Section G)
I.T.S. GMBH
autal 28
lassnitzh[?]he, styria 8301
AU   8301
Manufacturer Contact
florian grill
autal 28
lassnitzh[?]he, styria 8301
AU   8301
MDR Report Key14427122
MDR Text Key291937540
Report Number3004369035-2022-00008
Device Sequence Number1
Product Code HRS
UDI-Device Identifier09120034307058
UDI-Public09120034307058
Combination Product (y/n)Y
Reporter Country CodeSF
PMA/PMN Number
K093868
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 05/17/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/18/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number21302-9
Device Catalogue Number21302-9
Was Device Available for Evaluation? No
Date Manufacturer Received05/03/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age51 YR
Patient Weight78 KG
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