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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAKO SURGICAL CORP. PELVIC ARRAY ADAPTOR ASSY ORTHOPEDIC STEREOTAXIC INSTRUMENT

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MAKO SURGICAL CORP. PELVIC ARRAY ADAPTOR ASSY ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 112240
Device Problem Material Frayed (1262)
Patient Problems Tissue Damage (2104); No Known Impact Or Consequence To Patient (2692)
Event Date 02/18/2020
Event Type  malfunction  
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
On (b)(6) 2020 at (b)(6), a surgical technician loosened the side piece of the array with her fingers to dissemble it during closing on the back table. During this, a small splinter of metal poked through her glove and pierced her finger. The metal splinter was taken out and she was sent for bloodwork. The defective piece was sterilized and will be sent back for a replacement. Case type: tka.
 
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Brand NamePELVIC ARRAY ADAPTOR ASSY
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
daniela davila
2555 davie road
fort lauderdale, FL 33317
9546280700
MDR Report Key9837060
MDR Text Key183653697
Report Number3005985723-2020-00157
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K121064
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number112240
Device Catalogue Number112240
Device Lot Number19040715
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/19/2020
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 03/16/2020 Patient Sequence Number: 1
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