• 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. BAR EXTENSION STEREOTAXIC DEVICE, ROBOTICS

  • 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. BAR EXTENSION STEREOTAXIC DEVICE, ROBOTICS Back to Search Results
Model Number 210070
Device Problems Crack (1135); Material Frayed (1262); Sharp Edges (4013)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/13/2019
Event Type  malfunction  
Manufacturer Narrative
As part of the normal complaint follow-up, an evaluation of the event has been initiated by mako surgical. A supplemental report will be submitted when additional information becomes available.
 
Event Description
Stryker mako leg holders. Numerous pieces have exposed fibers, two pieces have stress fractures at the point where the metal fitting is inserted. Report of "someone getting stuck" by an exposed fiber. Case type: tka. Patient was under anesthesia. Update : how many surgeries were involved with the reported issue? approximately 300 procedures to get to this point. All the reported devices that are included in this complaint were for one or many surgeries? many ¿ spd called us concerned about exposed fibers and cracks. Have you reported each incident separately that has the issues you have mentioned in this complaint? (if no, please submit a complaint for each issue. ) no ¿ multiple leg holders are exhibiting wear. The items listed in the per either have exposed fibers or cracks. Please confirm if there was a patient that was ¿stuck¿ by the exposed carbon fiber? not a patient ¿ a staff member.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBAR EXTENSION
Type of DeviceSTEREOTAXIC DEVICE, ROBOTICS
Manufacturer (Section D)
MAKO SURGICAL CORP.
2555 davie road
fort lauderdale FL 33317
Manufacturer (Section G)
MAKO SURGICAL CORP.
2555 davie road
fort lauderdale FL 33317
Manufacturer Contact
alessandra chavez
2555 davie road
fort lauderdale, FL 33317
9546280700
MDR Report Key9577345
MDR Text Key178580662
Report Number3005985723-2020-00013
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/10/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number210070
Device Catalogue Number210070
Device Lot Number609572
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/27/2020
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 Treatment Data
Date Received: 01/10/2020 Patient Sequence Number: 1
-
-