• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAKO SURGICAL CORP. / STRYKER CORP. STRYKER MAKO CHECKPOINT

  • 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
 

MAKO SURGICAL CORP. / STRYKER CORP. STRYKER MAKO CHECKPOINT Back to Search Results
Model Number 111653
Device Problem Detachment of Device or Device Component (2907)
Patient Problem Foreign Body In Patient (2687)
Event Date 12/21/2018
Event Type  Injury  
Event Description
Patient in surgery for a right total hip replacement using stryker mako robotic arm interactive orthopedic system. Immediately upon removal of the pelvic checkpoint, it was noted that the tip of the checkpoint was retained in the superior acetabular bone stock. The area was exposed and the retained tip was nit visible above the cortical bone. The decision was made to leave the retained checkpoint tip rather than compromise the superior acetabular bone stock to search for the tip. Patient and his family were notified with this disclosure documented in the ehr.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSTRYKER MAKO CHECKPOINT
Type of DeviceCHECKPOINT
Manufacturer (Section D)
MAKO SURGICAL CORP. / STRYKER CORP.
MDR Report Key8206306
MDR Text Key131934268
Report NumberMW5082684
Device Sequence Number0
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 12/27/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/28/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number111653
Device Lot NumberW58827
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

-
-