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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAKO SURGICAL CORP. VARIABLE ANGLE CORTICAL SCREW, STERILE; ORTHOPEDIC STEREOTAXIC INSTRUMENT
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MAKO SURGICAL CORP. VARIABLE ANGLE CORTICAL SCREW, STERILE; ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 111655
Device Problem Insufficient Information (3190)
Patient Problems Bone Fracture(s) (1870); Hip Fracture (2349)
Event Date 02/17/2020
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
Tha with mako (direct anterior approach).Used enhanced workflow, so used variable cortical screw around proximal femur.Procedure was completed without any problem.Greater trochanter fracture was happened probably during rehabilitation.Sales rep was informed that 3 similar cases happened.In surgeon's opinion, this event happened due to use of variable cortical screw, but direct cause was unknown.Another possibility is that bone is thin around greater trochanter because they used anterior approach.In addition, there is a possibility that the screw may interfere many times during retraction of the femur or trial.Whether to perform revision surgery is undecided.
 
Event Description
Tha with mako (direct anterior approach).Used enhanced workflow, so used variable cortical screw around proximal femur.Procedure was completed without any problem.Greater trochanter fracture was happened probably during rehabilitation.Sales rep was informed that 3 similar cases happened.In surgeon's opinion, this event happened due to use of variable cortical screw, but direct cause was unknown.Another possibility is that bone is thin around greater trochanter because they used anterior approach.In addition, there is a possibility that the screw may interfere many times during retraction of the femur or trial.Whether to perform revision surgery is undecided.Direct anterior approach.
 
Manufacturer Narrative
Reported event: tha with mako (direct anterior approach).Used enhanced workflow, so used variable cortical screw around proximal femur.Procedure was completed without any problem.Greater trochanter fracture was happened probably during rehabilitation.Sales rep was informed that 3 similar cases happened.In surgeon's opinion, this event happened due to use of variable cortical screw, but direct cause was unknown.Another possibility is that bone is thin around greater trochanter because they used anterior approach.In addition, there is a possibility that the screw may interfere many times during retraction of the femur or trial.Whether to perform revision surgery is undecided.Product evaluation and results: product inspection was not performed as product was not returned for inspection.Product history review: product history review was not conducted as lot number is not provided.Complaint history review: complaint history review was not conducted as lot number is not provided.Conclusions: the failure mode could not be confirmed because the part was not available for evaluation.If device and/or additional information become available, this investigation will be reopened.H3 other text: device not returned.
 
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Brand Name
VARIABLE ANGLE CORTICAL SCREW, STERILE
Type of Device
ORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
MAKO SURGICAL CORP.
2555 davie road
fort lauderdale FL 33317
MDR Report Key9837995
MDR Text Key183772204
Report Number3005985723-2020-00163
Device Sequence Number1
Product Code OLO
UDI-Device Identifier00848486017323
UDI-Public00848486017323
Combination Product (y/n)N
PMA/PMN Number
K112507
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 07/15/2020
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 Model Number111655
Device Catalogue Number111655
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 02/17/2020
Initial Date FDA Received03/16/2020
Supplement Dates Manufacturer Received06/23/2020
Supplement Dates FDA Received07/15/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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