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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: K2M. INC MESA SPINAL SYSTEM; ORTHOSIS, SPINAL PEDICAL FIXATION,
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K2M. INC MESA SPINAL SYSTEM; ORTHOSIS, SPINAL PEDICAL FIXATION, Back to Search Results
Catalog Number 801-90053
Device Problem Insufficient Information (3190)
Patient Problem No Information (3190)
Event Date 03/07/2019
Event Type  Injury  
Manufacturer Narrative
A comprehensive investigation was immediately initiated on receipt of the complaint.The subject product has not been returned for evaluation yet.Investigation is still in process.When investigation is complete, k2m inc.Will file a supplemental report indicating the findings.
 
Event Description
On (b)(6) 2019 it was reported to k2m, inc.That a surgery took place in which three screw inserters and screw removal tool broke at the tip intraoperatively.It is unknown if the patient was revised.(related to 3004774118-2019-00037).
 
Manufacturer Narrative
Upon receipt of further detail it was determined that the revision surgery was planned and was not due to a product problem.
 
Event Description
On (b)(6) 2019 it was reported to k2m, inc.That a surgery took place in which three screw inserters and screw removal tool broke at the tip intra-operatively.It is unknown if revision was related to a device problem.(related to 3004774118-2019-00037).
 
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Brand Name
MESA SPINAL SYSTEM
Type of Device
ORTHOSIS, SPINAL PEDICAL FIXATION,
Manufacturer (Section D)
K2M. INC
600 hope parkway se
leesburg, va 20175
MDR Report Key8471567
MDR Text Key141444799
Report Number3004774118-2019-00029
Device Sequence Number1
Product Code MNI
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 04/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/01/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number801-90053
Device Lot NumberBXBW014,AHAG005, ANTJ
Was Device Available for Evaluation? No
Date Manufacturer Received03/07/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
801-90001 LOT CKVT; 801-9001 LOT CKVT
Patient Outcome(s) Required Intervention;
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