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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP LARGE POINTER; NEUROLOGICAL STEREOTAXIC INSTRUMENT

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STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP LARGE POINTER; NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 6000-011-000
Device Problems Incorrect Measurement (1383); Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/18/2022
Event Type  malfunction  
Event Description
Per the customer, the device's tip was bent during a procedure which could lead to an inaccuracy.The procedure was completed successfully without a clinically significant delay; no adverse consequences or medical intervention were reported.
 
Manufacturer Narrative
Update: d9, h3, h6.Device evaluation: follow-up report submitted to document the device was not available for evaluation.H3 other text : no product return per the customer.
 
Event Description
Per the customer, the device's tip was bent during a procedure which could lead to an inaccuracy.The procedure was completed successfully without a clinically significant delay; no adverse consequences or medical intervention were reported.
 
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Brand Name
LARGE POINTER
Type of Device
NEUROLOGICAL STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP
1941 stryker way
portage MI 49002
Manufacturer (Section G)
STRYKER INSTRUMENTS-FREIBURG
boetzingerstr. 41
freiburg D-791 11
GM   D-79111
Manufacturer Contact
colette chung
1941 stryker way
portage, MI 49002
2693237700
MDR Report Key14987950
MDR Text Key295713580
Report Number3015967359-2022-01284
Device Sequence Number1
Product Code HAW
UDI-Device Identifier04546540245106
UDI-Public04546540245106
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K993239
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 09/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number6000-011-000
Device Catalogue Number6000-011-000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 06/20/2022
Initial Date FDA Received07/12/2022
Supplement Dates Manufacturer Received09/19/2022
Supplement Dates FDA Received09/21/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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