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U.S. Department of Health and Human Services

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

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MAKO SURGICAL CORP. UNKNOWN ROBOT; STEREOTAXIC DEVICE, ROBOTICS Back to Search Results
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.".
 
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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 Key12051977
MDR Text Key257846894
Report Number3005985723-2021-00112
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Number of Events Reported1
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 NumberUNK_OFL
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 05/28/2021
Initial Date FDA Received06/23/2021
Supplement Dates Manufacturer Received09/17/2021
Supplement Dates FDA Received10/11/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age80 YR
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