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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORTHALIGN, INC. REFERENCE SENSOR 5 HIP REFERENCE SENSOR RS5H

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ORTHALIGN, INC. REFERENCE SENSOR 5 HIP REFERENCE SENSOR RS5H Back to Search Results
Model Number 403087-06
Device Problems Incorrect, Inadequate or Imprecise Resultor Readings (1535); No Apparent Adverse Event (3189)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/13/2021
Event Type  malfunction  
Manufacturer Narrative
No fault could be found with the returned reference sensor 5h. The reference sensor passed all visual and functional tests. A review of the device history record (dhr) was conducted. The device passed all manufacturing specifications prior to release. Orthalign, inc. Will continue to monitor this issue and take action if alert limits are exceeded. Orthalign will continue to monitor this issue and take action if or when alert limits are exceeded.
 
Event Description
It was reported that the unit doesn't work. The sensor was not providing accurate results. The cups version and abduction was just way off from the stated position.
 
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Brand NameREFERENCE SENSOR 5 HIP
Type of DeviceREFERENCE SENSOR RS5H
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 Key12697624
MDR Text Key278387524
Report Number3007521480-2021-00026
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K171780
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/11/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/26/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number403087-06
Device Catalogue Number403087-06
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/07/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/11/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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