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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAKO SURGICAL CORP. CHECKPOINT 3.5MM HEX X 15MM STERILE; ORTHOPEDIC STEREOTAXIC INSTRUMENT
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MAKO SURGICAL CORP. CHECKPOINT 3.5MM HEX X 15MM STERILE; ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 116230
Medical Device Problem Code Use of Device Problem (1670)
Health Effect - Clinical Code Foreign Body In Patient (2687)
Date of Event 12/01/2025
Type of Reportable Event Malfunction
Event or Problem Description
During acetabular reaming at mtha, the checkpoint screw hex 3.5mm installed in the pelvis was accidentally shaved off.The screw was worn down inside the body.
 
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Brand Name
CHECKPOINT 3.5MM HEX X 15MM STERILE
Common Device Name
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
sanjana talathi
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key23879853
Report Number3005985723-2025-00629
Device Sequence Number21198399
Product Code OLO
UDI-Device Identifier00848486002978
UDI-Public00848486002978
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K170593
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source Other
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 12/23/2025
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Catalogue Number116230
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 12/01/2025
Initial Report FDA Received Date12/23/2025
Was Device Evaluated by Manufacturer? (Y/N) No
Is the Device Labeled for Single Use? (Y/N) Yes
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Initial
Patient Sequence Number1
Patient SexUnknown
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