MAUDE Adverse Event Report: MAKO SURGICAL CORP. MAKO ROBOTIC ARM 3.1 ORTHOPEDIC STEREOTAXIC INSTRUMENT

Model Number 219999

Device Problems Incorrect, Inadequate or Imprecise Resultor Readings (1535); Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/09/2021

Event Type  malfunction  

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

Rob932 - mps reported ligament balancing numbers very off in tka case. Mps went to ct landmarks from ligament balancing and noticed the segmentation seemed to have shifted which concerned the surgeon, although this is a known bug. Surgeon is requesting a visit to investigate why the ligament balancing values did not match their clinical diagnosis.

• Brand Name: MAKO ROBOTIC ARM 3.1
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• 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 Key: 12120414
• MDR Text Key: 260052966
• Report Number: 3005985723-2021-00120
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 10/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 219999
• Device Catalogue Number: 219999
• Device Lot Number: ROB932
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 09/30/2021
• 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: 07/06/2021 Patient Sequence Number: 1