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

MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MAKO ROBOTIC ARM 3.1 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
 

STRYKER ORTHOPAEDICS-MAHWAH MAKO ROBOTIC ARM 3.1 STEREOTAXIC DEVICE, ROBOTICS Back to Search Results
Model Number 219999
Device Problem Insufficient Information (3190)
Patient Problems Unspecified Infection (1930); Injection Site Reaction (4562)
Event Date 10/01/2020
Event Type  Injury  
Manufacturer Narrative
As part of 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
It was reported through the submission of a revision usage sheet that the patient's right knee was revised. A 2x11 ts insert was implanted. Update 05/october/2020 wg: sales branch provided the primary usage sheet. A 2x9 ts insert was revised to a 2x11 ts insert. Update: "patient was treated with i&d due to acute infection. X-rays/removed polyethylene are not available. ".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMAKO ROBOTIC ARM 3.1
Type of DeviceSTEREOTAXIC DEVICE, ROBOTICS
Manufacturer (Section D)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer (Section G)
STRYKER ORTHOPAEDICS-MAHWAH
325 corporate drive
mahwah NJ 07430
Manufacturer Contact
joanne mahony
ida industrial estate
carrigtwohill, NJ NA
EI   NA
2018315000
MDR Report Key10762456
MDR Text Key213878995
Report Number3005985723-2020-00330
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 health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/30/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number219999
Device Catalogue Number219999
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/20/2021
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: 10/30/2020 Patient Sequence Number: 1
-
-