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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAKO SURGICAL CORP. UNKNOWN MAKO ONLAY TUBE INSERT 010370 ORTHOPEDIC STEREOTAXIC INSTRUMENT

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MAKO SURGICAL CORP. UNKNOWN MAKO ONLAY TUBE INSERT 010370 ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number UNK_OFL
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Pain (1994)
Event Date 09/13/2021
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. The following devices were also listed in this report: mck femoral-rm-ll-sz 5;180515;unknown, mck tibial baseplate-rm/ll-sz 5;180615; unknown. It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience. Device not returned.
 
Event Description
Patient that had a mako knee surgery in 2019 is presenting pain. Op date: (b)(6). Item ¿ palacos r & g 40g with gentamicin bone cement 0. 5g gentamicin. Mako fem. Comp. 180515. Mako onlay tib 180615. Mako onlay tube insert 010370.
 
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Brand NameUNKNOWN MAKO ONLAY TUBE INSERT 010370
Type of DeviceORTHOPEDIC 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
alessandra chavez
2555 davie road
fort lauderdale, FL 33317
9546280700
MDR Report Key12587255
MDR Text Key276194841
Report Number3005985723-2021-00166
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial
Report Date 10/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/06/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK_OFL
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/13/2021
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 Treatment Data
Date Received: 10/06/2021 Patient Sequence Number: 1
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