MAUDE Adverse Event Report: MAKO SURGICAL CORP. UNKNOWN 111653 FEMORAL CHECKPOINT STEREOTAXIC DEVICE, ROBOTICS

Catalog Number UNK_OFL

Device Problems Difficult to Remove (1528); Appropriate Term/Code Not Available (3191)

Patient Problems Injury (2348); Foreign Body In Patient (2687)

Event Date 12/18/2019

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

Tha surgery was performed using mako. Prior to pelvic registration, impact driver was used to place a pelvic checkpoint screw on the illiac above the acetabulum. As a result, screw penetrated the bone and embedded on the extra-abdominal pelvis. For a while, surgeon tried to remove the screw using inoperative images, but it was difficult to remove with that approach. Surgeon decided to continue procedure without removing the screw. Will perform a ct scan and determine whether to remove the screw.

• Brand Name: UNKNOWN 111653 FEMORAL CHECKPOINT
• 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: daniela davila ; 2555 davie road; fort lauderdale, FL 33317 ; 9546280700
• MDR Report Key: 9594226
• MDR Text Key: 175447607
• Report Number: 3005985723-2020-00035
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 04/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: UNK_OFL
• Device Lot Number: UNKNOWN
• 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 Received: 03/27/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 01/15/2020 Patient Sequence Number: 1