MAUDE Adverse Event Report: MAKO SURGICAL CORP. UNKNOWN ROBOT; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number UNK_OFL

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

Patient Problem Bone Fracture(s) (1870)

Event Date 05/28/2021

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

User feedback reported: "due to osteoporosis, per surgeon and fracture occurred preparing femur ps box.".

Manufacturer Narrative

Reported event: user feedback reported: "due to osteoporosis, per surgeon and fracture occurred preparing femur ps box.".Method & results: product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Clinician review: no medical records were received for review with a clinical consultant.Product history review: could not be performed as the device lot details were not provided.Complaint history review: could not be performed as the device lot details were not provided.Conclusions: the alleged failure mode was not confirmed because the product was not available for inspection.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.H3 other text : device not returned.

Event Description

User feedback reported: "due to osteoporosis, per surgeon and fracture occurred preparing femur ps box.".

• Brand Name: UNKNOWN ROBOT
• Type of Device: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 12051977
• MDR Text Key: 257846894
• Report Number: 3005985723-2021-00112
• 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: company representative
• Type of Report: Initial,Followup
• Report Date: 10/11/2021

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: UNK_OFL
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/28/2021
• Initial Date FDA Received: 06/23/2021
• Supplement Dates Manufacturer Received: 09/17/2021
• Supplement Dates FDA Received: 10/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 80 YR