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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: K2M, INC. UNKNOWN_K2M_PRODUCT; UNKNOWN ROD
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K2M, INC. UNKNOWN_K2M_PRODUCT; UNKNOWN ROD Back to Search Results
Catalog Number UNK_SPE
Device Problem Insufficient Information (3190)
Patient Problem Insufficient Information (4580)
Event Date 01/11/2017
Event Type  Injury  
Manufacturer Narrative
Status and location of the device is unknown.
 
Event Description
Revision surgery was performed approximately 1 month post-operatively where a mesa screw at l3 was removed and replaced as well as the right side cobalt chromium rod.The reason for removal and replacement is unknown at this time.This report captures the cobalt chromium rod.
 
Event Description
Revision surgery was performed approximately 1 month post-operatively where a mesa screw at l3 was removed and replaced as well as the right side cobalt chromium rod.The reason for removal and replacement is unknown at this time.This report captures the cobalt chromium rod.
 
Manufacturer Narrative
Visual, dimensional, functional and material analysis could not be performed as the device was not returned.Device and complaint history records review could not be performed as a valid lot code was not provided and could not be obtained.The index level of the initial procedure was l4-5, this event was related to the adjacent level above.This event was initially reported as related to the surgery, yet relation to the device was listed as "unknown".Multiple attempts at receiving additional information were made, but nothing was received.Since device failure mode is unknown and device was not returned, an exact cause of the reported event cannot be determined.
 
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Brand Name
UNKNOWN_K2M_PRODUCT
Type of Device
UNKNOWN ROD
Manufacturer (Section D)
K2M, INC.
600 hope parkway se
leesburg VA 20175
MDR Report Key11863704
MDR Text Key252407723
Report Number3004774118-2021-00149
Device Sequence Number1
Product Code KWP
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 09/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/21/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberUNK_SPE
Was Device Available for Evaluation? No
Date Manufacturer Received08/27/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age71 YR
Patient Weight57
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