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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MERGE HEALTHCARE, AN IBM COMPANY MERGE ORTHOCASE

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MERGE HEALTHCARE, AN IBM COMPANY MERGE ORTHOCASE Back to Search Results
Model Number MERGE ORTHOCASE 3.7.2.869
Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/26/2016
Event Type  malfunction  
Manufacturer Narrative
After further investigation, it was found the customer was using 3 different size balls during their x-ray of a patient's hip. These balls were taped to the customer to provide a measurement scale for the template. When the images were uploaded to the template, it was found the template took the average of the different size balls to calculate a measurement. This resulted in the template producing incorrect measurements prior to surgery. These templates are designed to help the surgeon plan for surgery using implants. During surgery, it was found the measurements from the template did not match the actual measurements in surgery. This was an inconvenience to the surgeon. There was no impact to surgery, and the customer confirmed surgery was successful.
 
Event Description
Merge orthocase is used for orthopedic applications and consists of features that allow the qualified medical professional to make measurements that are commonly required when doing orthopedic surgical planning. On (b)(6) 2016 a customer reported incorrect measurements from the template in merge orthocase. The customer used the template to measure an area for surgery and what size implants will be used. During the surgery they found that area they measured on the image was off 4-6 mm. This event was highly detectable by the surgeon and he was able to re-measure and use correct size implant. This issue has a potential for use of an incorrectly sized implant during orthopedic surgery. The customer confirmed the surgery was successful and there was no harm to the patient. (b)(4).
 
Manufacturer Narrative
After further investigation, it was found the customer was using different size balls which caused the template to not produce correct measurements. No additional corrective actions are needed.
 
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Brand NameMERGE ORTHOCASE
Type of DeviceMERGE ORTHOCASE
Manufacturer (Section D)
MERGE HEALTHCARE, AN IBM COMPANY
900 walnut ridge dr
hartland WI 53029
Manufacturer (Section G)
MERGE HEALTHCARE, AN IBM COMPANY
900 walnut ridge dr
hartland WI 53029
Manufacturer Contact
mike diedrek
900 walnut ridge dr
hartland, WI 53029
2629123570
MDR Report Key5684213
MDR Text Key46070195
Report Number2183926-2016-00589
Device Sequence Number1
Product Code LLZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K022881
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/26/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/26/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMERGE ORTHOCASE 3.7.2.869
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/26/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/30/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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