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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAKO SURGICAL CORP. UNKNOWN_ROB1464 TKA CHECKPOINT; ORTHOPEDIC STEREOTAXIC INSTRUMENT
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MAKO SURGICAL CORP. UNKNOWN_ROB1464 TKA CHECKPOINT; ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number UNK_OFL
Device Problem Insufficient Information (3190)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/03/2021
Event Type  Injury  
Manufacturer Narrative
As part of normal complaint follow-up, an evaluation of the event has been initiated by mako surgical.If additional information becomes available, a supplemental report will be submitted.
 
Event Description
Two checkpoints were left in patient, as a result patient was sent back for removal.Case type / application: tka.
 
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Brand Name
UNKNOWN_ROB1464 TKA CHECKPOINT
Type of Device
ORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
MAKO SURGICAL CORP.
2555 davie road
fort lauderdale FL 33317
Manufacturer (Section G)
MAKO SURGICAL CORP.
2555 davie road
fort lauderdale FL 33317
Manufacturer Contact
marisol santiago
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key12366176
MDR Text Key268088150
Report Number3005985723-2021-00148
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other
Type of Report Initial
Report Date 08/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/25/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberUNK_OFL
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received08/03/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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