Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: K2M, INC. EXPANDABLE DRILL GUIDE; SIZE 15 MM; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

K2M, INC. EXPANDABLE DRILL GUIDE; SIZE 15 MM; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR Back to Search Results
Model Number 2008-90177
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/31/2022
Event Type  malfunction  
Event Description
A company representative reported that the chesapeake expandable drill guide disengaged from the implant during surgery while the surgeon was preparing a pilot hole for the second screw.The drill guide was not reattached and the second screw was inserted freehand into the partially prepared hole.The third screw was not implanted.The chesapeake anterior lumbar implant was placed with only two of the three screws so that the device was only instrumented to a single adjacent vertebral body.This report captures the chesapeake expandable drill guide.
 
Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device was not returned.Device history records could not be reviewed as a valid lot number was not provided and could not be obtained.Complaint history records were reviewed for this catalog number, and no adverse trends were observed.A company representative reported that the chesapeake expandable drill guide disengaged from the implant during surgery while the surgeon was removing awl for the second screw hole.The drill guide was not reattached and the second screw was inserted freehand into the previously created pilot hole.Only 2 screws were used instead of 3.The surgery was being performed at l5-s1.The patient was closed and the surgeon intends to follow up with a posterior fixation case at a later date.It was confirmed that no trouble was faced with the device while attaching or holding the implant.It is likely that the drill guide was not attached adequately with the implant and disengaged while removing the awl during the surgery.
 
Event Description
A company representative reported that the chesapeake expandable drill guide disengaged from the implant during surgery while the surgeon was preparing a pilot hole for the second screw.The drill guide was not reattached and the second screw was inserted freehand into the partially prepared hole.The third screw was not implanted.The chesapeake anterior lumbar implant was placed with only two of the three screws so that the device was only instrumented to a single adjacent vertebral body.This report captures the chesapeake expandable drill guide.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
EXPANDABLE DRILL GUIDE; SIZE 15 MM
Type of Device
INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR
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 Key13654447
MDR Text Key286472621
Report Number3004774118-2022-00074
Device Sequence Number1
Product Code OVD
UDI-Device Identifier10888857181243
UDI-Public10888857181243
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K142487
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 06/07/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number2008-90177
Device Catalogue Number2008-90177
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 01/31/2022
Initial Date FDA Received03/02/2022
Supplement Dates Manufacturer Received05/09/2022
Supplement Dates FDA Received06/07/2022
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Age54 YR
Patient SexFemale
-
-