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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: K2M, INC. UNKNOWN_K2M_PRODUCT; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
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K2M, INC. UNKNOWN_K2M_PRODUCT; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Catalog Number UNK_SPE
Device Problem Malposition of Device (2616)
Patient Problems Bone Fracture(s) (1870); Insufficient Information (4580)
Event Date 03/12/2021
Event Type  Injury  
Manufacturer Narrative
Device remains implanted.
 
Event Description
It was reported that following a revision surgery to replace two mesa screws, one of the screws was replaced incorrectly and the patient has sustained a transverse injury.Additional information is not available at this time.
 
Manufacturer Narrative
Corrected information: d6a -implant date.Visual, dimensional, material and functional 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.Per reported event, most likely cause is user error- incorrect screw placement/ trajectory.Patient's hard bone quality may have also contributed to difficulty in removing the screw.
 
Event Description
It was reported that following a revision surgery to replace two mesa screws, one of the screws was replaced incorrectly and the patient has sustained a transverse injury.Additional information is not available at this time.
 
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Brand Name
UNKNOWN_K2M_PRODUCT
Type of Device
THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
Manufacturer (Section D)
K2M, INC.
600 hope parkway se
leesburg VA 20175
MDR Report Key11628053
MDR Text Key244206809
Report Number3004774118-2021-00100
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
PMA/PMN Number
K141873
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial,Followup
Report Date 07/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/07/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberUNK_SPE
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received06/30/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age17 YR
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