MAUDE Adverse Event Report: MAKO SURGICAL CORP. UNKNOWN_JOINT REPLACEMENT_ROBOTICS_PRODUCT STEREOTAXIC DEVICE, ROBOTICS

Catalog Number UNK_OFL

Device Problems Output Problem (3005); Insufficient Information (3190)

Patient Problem Bone Fracture(s) (1870)

Event Date 12/18/2017

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

As reported: "it is reported by counsel for claimant (b)(6); dob (b)(6) that claimant received a ltka performed by dr. (b)(6) at the (b)(6) clinic in (b)(6) on (b)(6) 2017. A mako unit was used during the surgery. Two weeks following her ltka, the claimant experienced a femur fracture. According to counsel, the fracture was due to a weakness in the femur resulting from the pinhole used for mako computer navigation. The claimant required an internal fixation on (b)(6) 2017 to repair the fracture and experienced subsequent complications. Claimant is a resident of (b)(6). This event is for the navigation pin.

• Brand Name: UNKNOWN_JOINT REPLACEMENT_ROBOTICS_PRODUCT
• 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: bethany hinson ; 2555 davie road; fort lauderdale, FL 33317 ; 9546280700
• MDR Report Key: 7315977
• MDR Text Key: 101578874
• Report Number: 3005985723-2018-00132
• 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: other

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 03/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: UNK_OFL
• 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: 03/15/2019
• Was Device Evaluated by Manufacturer?: No
• 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: 03/06/2018 Patient Sequence Number: 1