• 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. ORTHOPEDIC STEREOTAXIC INSTRUMENT

  • 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. ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 213524
Device Problems Break (1069); Entrapment of Device (1212)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 10/14/2021
Event Type  malfunction  
Event Description
The schanz screw broke at the surface of the bone when drilling in. Broken piece confined to the tibia and did not extend out the cortex. Retained pin not removed to avoid more trauma.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameNA
Type of DeviceORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
MAKO SURGICAL CORP.
2555 davie road
fort lauderdale FL 33317
MDR Report Key13590942
MDR Text Key286059425
Report Number13590942
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 02/10/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/24/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number213524
Device Catalogue Number213524
Device Lot Number48050421
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/10/2022
Event Location Hospital
Date Report to Manufacturer02/24/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Type of Device Usage Unkown

-
-