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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER GMBH PROXIMAL LATERAL HUMERUS PLATE TS AXSOS FOR LEFT HUMERUS 10 HOLE, L176MM PLATE, FIXATION, BONE

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STRYKER GMBH PROXIMAL LATERAL HUMERUS PLATE TS AXSOS FOR LEFT HUMERUS 10 HOLE, L176MM PLATE, FIXATION, BONE Back to Search Results
Catalog Number 437110S
Device Problem Bent (1059)
Patient Problem Fall (1848)
Event Date 01/30/2018
Event Type  Injury  
Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
 
Event Description
As reported: "revision scheduled for friday (b)(6) 2018. Patient is said to have fallen and that's why the plate bent/ failed. " rep provided an x-ray provided to her on (b)(6) 2018. Left side.
 
Manufacturer Narrative
The reported event that proximal lateral humerus plate ts axsos for left humerus 10 hole, l176mm was alleged of 'device deformed' could be confirmed. Based on investigation, the root cause was attributed to be patient related. The failure was caused due to a fall of the patient. The device inspection revealed the following: it is clearly evident that the returned revised proximal lateral humerus plate is indeed badly bent / deformed. Which is surely the result of the patient fall (as reported). Screws were still intact though. A review of the device history for the reported lot did not indicate any abnormalities. No corrective actions are required at this time. A review of the labeling did not indicate any abnormalities. No indications of material, manufacturing or design related problems were found during the investigation. If any further information is provided, the investigation report will be updated.
 
Event Description
As reported: "revision scheduled for friday (b)(6) 2018. Patient is said to have fallen and that's why the plate bent/ failed. " rep provided an x-ray provided to her on (b)(6) 2018. Left side.
 
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Brand NamePROXIMAL LATERAL HUMERUS PLATE TS AXSOS FOR LEFT HUMERUS 10 HOLE, L176MM
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 Key7294123
MDR Text Key100885402
Report Number0008031020-2018-00135
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K110476
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 04/23/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/23/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/01/2018
Device Catalogue Number437110S
Device Lot NumberR28981
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/20/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/27/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured12/23/2013
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: 02/23/2018 Patient Sequence Number: 1
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