MAUDE Adverse Event Report: MAKO SURGICAL CORP. 3.0 RIO ROBOTIC ARM - MICS; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number 209999

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Loss of Range of Motion (2032)

Event Date 02/02/2024

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 if additional information becomes available.

Event Description

As described by distributor: "on the date of surgery post cuts the surgeon noted the implant was not flush on the chamfer cuts.Robot checks fine, no bumped arrays or issues with probes.2 weeks post op xray noted a gap on the anterior and posterior chamfer and again at 6 weeks.Patient is complaining of tightness and range of 0-90 degrees.The surgeon has notified the mps and will be keeping an eye on this patient going forward.".

• Brand Name: 3.0 RIO ROBOTIC ARM - MICS
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MAKO SURGICAL CORP.; 3365 enterprise ave; weston FL 33331
• Manufacturer (Section G): MAKO SURGICAL CORP.; 3365 enterprise ave; weston FL 33331
• Manufacturer Contact: olive flood ; raheen business park; limerick NA ; EI NA ; 61498200
• MDR Report Key: 19162588
• MDR Text Key: 340798363
• Report Number: 3005985723-2024-00047
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00848486030407
• UDI-Public: 00848486030407
• Combination Product (y/n): N
• Reporter Country Code: EI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 209999
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/27/2024
• Initial Date FDA Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other