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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO ORTHOLOCK EX-PIN 3 X 110; NEUROLOGICAL STEREOTAXIC INSTRUMENT
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STRYKER INSTRUMENTS-KALAMAZOO ORTHOLOCK EX-PIN 3 X 110; NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 6007103110
Device Problem Fracture (1260)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/14/2016
Event Type  malfunction  
Event Description
It was reported that during a surgical procedure conducted at the user facility the tip of the pin broke off in the patient's tibia.A delay with an unknown length of time was reported, as well as no adverse consequences to the patient.
 
Manufacturer Narrative
No further information was available; therefore, the evaluation was not completed.
 
Event Description
It was reported that during a surgical procedure conducted at the user facility the tip of the pin broke off in the patient's tibia.A delay with an unknown length of time was reported, as well as no adverse consequences to the patient.
 
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Brand Name
ORTHOLOCK EX-PIN 3 X 110
Type of Device
NEUROLOGICAL STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
Manufacturer (Section G)
STRYKER INSTRUMENTS-FREIBURG
boetzingerstr. 41
postfach
freiburg D-791 11
Manufacturer Contact
casey metzger
instruments division
carrigtwohill bus. & tech park
carrigtwohill, MI NA
2693237700
MDR Report Key6165895
MDR Text Key62140537
Report Number0001811755-2016-02831
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K022365
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 01/05/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/12/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number6007103110
Device Lot NumberV32449
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/14/2016
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age80 YR
Patient Weight108
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