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

Model Number 209999

Device Problem Insufficient Information (3190)

Patient Problem Abscess (1690)

Event Date 04/03/2019

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

During a mako clinical trial adverse event data report it was found that a patient had a wound abscess.Patient required antibiotics, and aquacel dressing.

Event Description

During a mako clinical trial adverse event data report it was found that a patient had a wound abscess.Patient required antibiotics, and aquacel dressing.

Manufacturer Narrative

Update to d2.Reported event: it was reported ¿during a mako clinical trial adverse event data report it was found that a patient had a wound abscess.Patient required antibiotics, and aquacel dressing.¿ product evaluation and results: review of the case session files was not performed as case session data was not provided.Product history review review of the device history records was not completed as the robot number was not provided.Complaint history review: a search of the complaint database under device identification pn 209999 reports no similar complaints for tka software - other.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Additional information including device details, operative reports, progress notes, x-rays, return of the device and case session data/logs are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.H3 other text : device not returned.

• Brand Name: 3.0 RIO® ROBOTIC ARM - MICS
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 9780156
• MDR Text Key: 181782225
• Report Number: 3005985723-2020-00125
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00848486030407
• UDI-Public: 00848486030407
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 05/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 209999
• Device Catalogue Number: 209999
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other