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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORTHALIGN, INC. ORTHALIGN PLUS; REFERENCE SENSOR

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ORTHALIGN, INC. ORTHALIGN PLUS; REFERENCE SENSOR Back to Search Results
Model Number 403087-06
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/12/2022
Event Type  malfunction  
Event Description
It was reported that the surgeon positioned the cup per the technique.The first time cup was registered with no incident.The second time the cup was registered it started at a normal value but then quickly started to drift away to different values.The drift was likely 10 degrees of anteversion before the 30 second timer ended.The third time the drift was not present.
 
Manufacturer Narrative
The reference sensor powered up and successfully passed horizontal, vertical, and side calibration.The sensor also successfully completed multiple simulated maneuvers during testing.The reference sensor was found to function as design.It is suspected that the root cause of the failure is a power failure within the navigation unit.The navigation unit was opened for inspection and it was found that one of the batteries had visible burn marks on the "positive" end, and the battery connector had burn marks as well.This can cause the unit to not perform as expected.There is no navigation log available for review.No fault could be found with the returned reference sensor 5 unit.A review of the device history record (dhr) was conducted.The device passed all manufacturing specifications prior to release.Orthalign will continue to monitor this issue and take action if or when alert limits are exceeded.
 
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Brand Name
ORTHALIGN PLUS
Type of Device
REFERENCE SENSOR
Manufacturer (Section D)
ORTHALIGN, INC.
120 columbia
suite 500
aliso viejo CA 92656
Manufacturer (Section G)
ORTHALIGN, INC.
120 columbia
suite 500
aliso viejo CA 92656
Manufacturer Contact
karyl haskell
120 columbia
suite 500
aliso viejo, CA 92656
MDR Report Key15200205
MDR Text Key305616461
Report Number3007521480-2022-00008
Device Sequence Number1
Product Code OLO
UDI-Device Identifier00851977007888
UDI-Public00851977007888
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K200642
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial
Report Date 08/09/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number403087-06
Device Catalogue Number403087-06
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/19/2022
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/12/2022
Initial Date FDA Received08/10/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/10/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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