MAUDE Adverse Event Report: MAKO SURGICAL CORP. FEMORAL/TIBIAL CHECKPOINT KIT -(STERILE) STEREOTAXIC DEVICE, ROBOTICS

Model Number 111645

Device Problems Fracture (1260); Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/29/2021

Event Type  Injury  

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

Checkpoints left in patient. Patient needed secondary surgery to remove checkpoints, and perform liner exchange.

• Brand Name: FEMORAL/TIBIAL CHECKPOINT KIT -(STERILE)
• Type of Device: STEREOTAXIC 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: anna ryan ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 12335839
• MDR Text Key: 267039795
• Report Number: 3005985723-2021-00143
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143752
• 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: 08/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 111645
• Device Catalogue Number: 111645
• Device Lot Number: UNKNOWN
• 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: 09/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 08/18/2021 Patient Sequence Number: 1