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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORTHALIGN, INC. ORTHALIGN PLUS; NAVIGATION UNIT

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ORTHALIGN, INC. ORTHALIGN PLUS; NAVIGATION UNIT Back to Search Results
Model Number 403001-05
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problems No Known Impact Or Consequence To Patient (2692); Joint Laxity (4526)
Event Date 07/09/2020
Event Type  malfunction  
Manufacturer Narrative
An orthalign distributor reported that during a total hip arthroplasty there was a malfunction with the navigation unit.While performing the cup implantation the accuracy of the navigation unit was off by greater than 3 degrees.Orthalign plus units have been cleared by the fda with the claim of +/- 3 degrees.An investigation will be performed once the unit is returned from orthalign inc.'s distributor in (b)(6).With an abundance of caution this report is being filed with the understanding of the potential patient harm that could result from an accuracy malfunction of greater than 3 degrees.A follow up report will be filed with the investigation findings.
 
Event Description
It was reported that total hip arthroplasty was performed with hipalign, supine approach.The surgeon planned that target cup angle was 40/15 degrees.The procedure was proceeded in accordance with the target cup angle.After cup impaction, the navigation showed that the cup was installed with 39/14 degrees (cup angle).Postoperatively, he confirmed x-ray photos of the cup angle and abduction angle of the cup was 56 degrees.
 
Manufacturer Narrative
An investigation of returned navigation unit log file found a significant change in cup values were displayed after the cup was impacted.The root cause of this issue is navigating the cup with the sensor attached to the impactor while impacting.Orthalign does not recommend navigating during impaction, it can cause damage and loss of navigation accuracy.Orthalign recommends navigating, taking the sensor off the impactor, then impacting.After impaction, the "check cup" feature can be utilized to verify results.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.
 
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Brand Name
ORTHALIGN PLUS
Type of Device
NAVIGATION UNIT
Manufacturer (Section D)
ORTHALIGN, INC.
120 columbia
suite 500
aliso viejo, ca
MDR Report Key10394279
MDR Text Key203147844
Report Number3007521480-2020-00011
Device Sequence Number1
Product Code OLO
UDI-Device Identifier00851977007901
UDI-Public00851977007901
Combination Product (y/n)N
PMA/PMN Number
K171780
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 08/05/2021
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 Number403001-05
Device Catalogue Number403001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/03/2020
Initial Date Manufacturer Received 07/22/2020
Initial Date FDA Received08/11/2020
Supplement Dates Manufacturer Received09/18/2020
Supplement Dates FDA Received08/09/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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