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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER TRAUMA KIEL END CAP, STD, TI GAMMA3®; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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STRYKER TRAUMA KIEL END CAP, STD, TI GAMMA3®; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 30051100S
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Code Available (3191)
Event Date 03/20/2019
Event Type  Injury  
Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
 
Event Description
It was reported that the patient underwent gamma3 u-lag screw surgery on (b)(6) 2019.After the surgery, the cutout of u-lag screw and the bending of u-blade were confirmed.Then gamma3 extraction and revision to tha was performed on (b)(6) 2019.
 
Event Description
It was reported that the patient underwent gamma3 u-lag screw surgery on (b)(6) 2019.After the surgery, the cutout of u-lag screw and the bending of u-blade were confirmed.Then gamma3 extraction and revision to tha was performed on (b)(6) 2019.
 
Manufacturer Narrative
This device is concomitant and did not contribute to the reported failure.If any additional information is provided indicating otherwise, the investigation will be updated accordingly.
 
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Brand Name
END CAP, STD, TI GAMMA3®
Type of Device
ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
STRYKER TRAUMA KIEL
prof. kuentscher-strasse 1-5
schoenkirchen/kiel D-242 32
MDR Report Key8483027
MDR Text Key140916177
Report Number0009610622-2019-00136
Device Sequence Number1
Product Code HSB
UDI-Device Identifier04546540374851
UDI-Public04546540374851
Combination Product (y/n)N
PMA/PMN Number
K032244
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 05/06/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/04/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue Number30051100S
Device Lot NumberK05277E
Was Device Available for Evaluation? Yes
Date Manufacturer Received04/16/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age89 YR
Patient Weight48
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