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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 Device Dislodged or Dislocated (2923)
Patient Problem Pain (1994)
Event Date 06/04/2019
Event Type  Injury  
Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
 
Event Description
Gamma3 primary surgery was performed on (b)(6) 2014.This time cutout of the lag screw was found.It is unknown when the cutout was occurred.The patient has felt pain but is able to walk.Revision surgery 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 record will be reopened and the investigation will be reworked.
 
Event Description
Gamma3 primary surgery was performed on (b)(6) 2014.This time cutout of the lag screw was found.It is unknown when the cutout was occurred.The patient has felt pain but is able to walk.Revision surgery to tha was performed on (b)(6) 2019.
 
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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 Key8732817
MDR Text Key149144804
Report Number0009610622-2019-00511
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 07/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/25/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Catalogue Number30051100S
Device Lot NumberK04A315
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/18/2019
Date Manufacturer Received07/09/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age80 YR
Patient Weight75
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