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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SYSTEM 6 ASEPTIC HOUSING; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
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STRYKER INSTRUMENTS-KALAMAZOO SYSTEM 6 ASEPTIC HOUSING; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT Back to Search Results
Catalog Number 6126120000
Device Problem Migration or Expulsion of Device (1395)
Patient Problem No Patient Involvement (2645)
Event Date 08/02/2016
Event Type  malfunction  
Event Description
During service at the manufacturing facility, it was observed that the o-ring was loose.There was no patient involvement, no adverse consequences, no medical intervention and no delays.
 
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Brand Name
SYSTEM 6 ASEPTIC HOUSING
Type of Device
INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
Manufacturer (Section G)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
Manufacturer Contact
casey metzger
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key5914120
MDR Text Key53484488
Report Number0001811755-2016-02039
Device Sequence Number1
Product Code HWE
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other
Type of Report Initial
Report Date 08/18/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/30/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number6126120000
Device Lot Number16028
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/17/2016
Date Manufacturer Received08/18/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/28/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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