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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH LOCKING COMPRESSION PLATE AXSOS 3 TI 9 HOLE / L123MM 4.0MM LOCKING PLATE, FIXATION, BONE

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STRYKER GMBH LOCKING COMPRESSION PLATE AXSOS 3 TI 9 HOLE / L123MM 4.0MM LOCKING PLATE, FIXATION, BONE Back to Search Results
Catalog Number 627509
Device Problems Break (1069); Appropriate Term/Code Not Available (3191)
Patient Problem Fall (1848)
Event Date 10/10/2018
Event Type  Injury  
Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
 
Event Description
It was reported that patient's left humerus was revised due to a broken plate. Surgeon reported patient had suffered two falls prior to revision. The plate and 7 screws were revised to an axsos 5. 0 broad compression plate. Rep reported that x-rays, medical records, and further information are not available due to hospital policy.
 
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Brand NameLOCKING COMPRESSION PLATE AXSOS 3 TI 9 HOLE / L123MM 4.0MM LOCKING
Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
CH 2545
Manufacturer (Section G)
STRYKER GMBH
bohnackerweg 1
postfach
selzach 2545
CH 2545
Manufacturer Contact
rose haas
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key8039721
MDR Text Key126218278
Report Number0008031020-2018-00944
Device Sequence Number0
Product Code HRS
Reporter Country CodeUS
PMA/PMN Number
K162439
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/05/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number627509
Device Lot NumberL47011
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/25/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/19/2018
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/05/2018 Patient Sequence Number: 1
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