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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 Problems Biocompatibility (2886); Insufficient Information (3190)
Patient Problem Bacterial Infection (1735)
Event Date 07/22/2022
Event Type  Injury  
Manufacturer Narrative
Device location unknown.
 
Event Description
It was reported that five patients implanted at the same facility were affected by mycobacterial infections post-operatively.The patient associated with this report required additional surgery for debridement with implant retention as well as prolonged antimicrobial treatment with multiple antibiotics.The patient is in currently in treatment.This report captures the fourth of five patients.
 
Manufacturer Narrative
H6 coding has been updated to reflect completion of the investigation.
 
Event Description
It was reported that five patients implanted at the same facility were affected by mycobacterial infections post-operatively.The patient associated with this report required additional surgery for debridement with implant retention as well as prolonged antimicrobial treatment with multiple antibiotics.The patient is in currently in treatment.This report captures the fourth of five patients.
 
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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
Manufacturer (Section G)
K2M, INC.
600 hope parkway se
leesburg VA 20175
Manufacturer Contact
rita karan
2 pearl court
allendale, NJ 07401
2017608000
MDR Report Key15845413
MDR Text Key304128691
Report Number3004774118-2022-00399
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeSP
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/17/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/22/2022
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
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/20/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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