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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: K2M, INC. UNKNOWN OZARK SCREW; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
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K2M, INC. UNKNOWN OZARK SCREW; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY Back to Search Results
Catalog Number UNK_SPE
Device Problem Insufficient Information (3190)
Patient Problem Insufficient Information (4580)
Event Date 02/23/2021
Event Type  malfunction  
Manufacturer Narrative
Location of device is unknown.
 
Event Description
A physician reported an unspecified "failure" of an ozark screw which occurred post-operatively.No other information has been provided.
 
Manufacturer Narrative
Visual, functional, and dimensional analysis could not be performed as the device associated with this issue was not identified nor returned.A review of complaint history and device history records could not be performed because identifying device information was not provided.As a device specific failure could not be identified nor confirmed, no further investigation is possible at this time and a root cause cannot be established.
 
Event Description
A physician reported an unspecified "failure" of an ozark screw which occurred post-operatively.No other information has been provided.
 
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Brand Name
UNKNOWN OZARK SCREW
Type of Device
APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
Manufacturer (Section D)
K2M, INC.
600 hope parkway se
leesburg VA 20175
MDR Report Key11564066
MDR Text Key242396277
Report Number3004774118-2021-00084
Device Sequence Number1
Product Code KWQ
Combination Product (y/n)N
PMA/PMN Number
K172104
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 06/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/24/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNK_SPE
Was Device Available for Evaluation? No
Date Manufacturer Received05/30/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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