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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAKO SURGICAL CORP. UNKNOWN HIP

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MAKO SURGICAL CORP. UNKNOWN HIP Back to Search Results
Catalog Number UNK_OFL
Device Problems Computer Software Problem (1112); Device Dislodged or Dislocated (2923)
Patient Problems Joint Dislocation (2374); No Known Impact Or Consequence To Patient (2692)
Event Date 10/02/2018
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.
 
Event Description
The staff cover the robot after setup with a large blue drape so no one bumps into it when they roll the patient into the room and everyone knows that it is sterile. I noticed when the staff took the large blue drape off the robot they were rough and it appeared they bumped the base array. When (b)(6) went to ream, the checkpoint on the offset reamer handle didn¿t pass (4. 3mm). He attempted to re-register the robot intra-operatively but became frustrated and said to ¿get the robot out of here. ¿ he finished the case without using the robot to ream, impact, and did not check leg length with it. I was told later in the day that the hip dislocated. I wanted to report this to document that the hip was completed without using the mako. Surgical delay -
=
15 minutes. Case type: tha.
 
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Brand NameUNKNOWN HIP
Type of DeviceUNKNOWN HIP
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
juana hiciano
325 corporate drive
mahwah, NJ 07430
2018315000
MDR Report Key7970078
MDR Text Key123864546
Report Number3005985723-2018-00591
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K170593
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 03/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/16/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK_OFL
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/28/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 10/16/2018 Patient Sequence Number: 1
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