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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NAVIGATION STRYKER ORTHOLOCK EX-PIN 3.310 TRACKER PIN

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STRYKER NAVIGATION STRYKER ORTHOLOCK EX-PIN 3.310 TRACKER PIN Back to Search Results
Model Number STRYKER ORTHOLOCK EX-PIN 3.110
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem Foreign Body In Patient (2687)
Event Date 03/10/2017
Event Type  malfunction  
Event Description
Two stryker ortholock ex-pin 3x110 tracker pin tips broke off during removal, and were unable to be removed without risk to the pt.
 
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Brand NameSTRYKER ORTHOLOCK EX-PIN 3.310
Type of DeviceTRACKER PIN
Manufacturer (Section D)
STRYKER NAVIGATION
4100 e. milham ave
kalamazoo ME 49001
MDR Report Key6409129
MDR Text Key70252409
Report NumberMW5068467
Device Sequence Number1
Product Code HAW
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 03/10/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/10/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSTRYKER ORTHOLOCK EX-PIN 3.110
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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