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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: I.T.S. GMBH STRAIGHT PLATE, 3.5MM, 9-HOLE
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I.T.S. GMBH STRAIGHT PLATE, 3.5MM, 9-HOLE Back to Search Results
Model Number 21102-9
Medical Device Problem Code Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code No Code Available (3191)
Date of Event 01/03/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The attachment of the complaint states that the patient fell out of bed, which produced the plate breakage.The device history record (dhr) of this plate 21102-9 were inspected and showed no deviations.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.
 
Event or Problem Description
It was reported that a straight plate, 3.5mm, 9-hole was determined to be broken postoperatively.Original implant date (b)(6) 2018.A revision surgery was performed on (b)(6) 2019.
 
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Brand Name
STRAIGHT PLATE, 3.5MM, 9-HOLE
Common Device Name
STRAIGHT PLATE, 3.5MM, 9-HOLE
Manufacturer (Section D)
I.T.S. GMBH
autal 28
lassnitzh?he, 8301
AU  8301
MDR Report Key8669639
Report Number3004369035-2019-00002
Device Sequence Number263623
Product Code HRS
UDI-Device Identifier09120034304743
UDI-Public09120034304743
Combination Product (Y/N)N
PMA/510(K) Number
K060156
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2019
Reporter Type Manufacturer
Report Source distributor
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 06/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Model Number21102-9
Device Catalogue Number21102-9
Device Lot Number147/13425C
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 05/31/2019
Initial Report FDA Received Date06/05/2019
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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