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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAKO SURGICAL CORP. CHECKPOINT, 3.5 HEX IMPACTION STERILE; ORTHOPEDIC STEREOTAXIC INSTRUMENT

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MAKO SURGICAL CORP. CHECKPOINT, 3.5 HEX IMPACTION STERILE; ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 111653
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Foreign Body In Patient (2687)
Event Date 03/11/2021
Event Type  Injury  
Manufacturer Narrative
Reported event: during mako tha procedure the patients wound was closed with the 3.5mm checkpoint still in the trochanter.The post op x-ray made the surgeon and staff aware.The patient was brought back into or to have the checkpoint removed.Product evaluation and results: product inspection was not performed as no evidence is provided for investigating.Product history review: product history review cannot be conducted as the lot number is not provided.Complaint history review: complaint history review cannot be conducted as the lot number is not provided.Conclusions: the failure cannot be determined as no evidence is provided for investigating.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.Device not returned.
 
Event Description
During mako tha procedure the patients wound was closed with the 3.5mm checkpoint still in the trochanter.The post op x-ray made the surgeon and staff aware.The patient was brought back into or to have the checkpoint removed.
 
Manufacturer Narrative
Reported event: during mako tha procedure the patients wound was closed with the 3.5mm checkpoint still in the trochanter.The post op x-ray made the surgeon and staff aware.The patient was brought back into or to have the checkpoint removed.Product evaluation and results: product inspection was not performed as no evidence is provided for investigating.Product history review: product history review cannot be conducted as the lot number is not provided.Complaint history review: complaint history review cannot be conducted as the lot number is not provided.Conclusions: the failure cannot be determined as no evidence is provided for investigating.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.H3 other text: device not available.
 
Event Description
During mako tha procedure the patients wound was closed with the 3.5mm checkpoint still in the trochanter.The post op x-ray made the surgeon and staff aware.The patient was brought back into or to have the checkpoint removed.
 
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Brand Name
CHECKPOINT, 3.5 HEX IMPACTION STERILE
Type of Device
ORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
MAKO SURGICAL CORP.
2555 davie road
fort lauderdale FL 33317
MDR Report Key11618456
MDR Text Key253505103
Report Number3005985723-2021-00061
Device Sequence Number1
Product Code OLO
UDI-Device Identifier00848486017316
UDI-Public00848486017316
Combination Product (y/n)N
PMA/PMN Number
K112507
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 04/26/2021
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 Model Number111653
Device Catalogue Number111653
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 03/11/2021
Initial Date FDA Received04/06/2021
Supplement Dates Manufacturer Received04/05/2021
Supplement Dates FDA Received04/26/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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