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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORTHALIGN, INC. KNEEALIGN 2 INSTRUMENT SET MICROBLOCK

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ORTHALIGN, INC. KNEEALIGN 2 INSTRUMENT SET MICROBLOCK Back to Search Results
Model Number 402042
Device Problems No Apparent Adverse Event (3189); Insufficient Information (3190)
Patient Problems Not Applicable (3189); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/15/2018
Event Type  malfunction  
Manufacturer Narrative
Orthalign, inc. Is filing this mdr in an abundance of caution with the understanding of the potential of an injury related to inaccurate instruments may cause in this type of orthopaedic surgery. An investigation will be preformed on the returned device. Once results and a conclusion is made available and follow-up form will be filed.
 
Event Description
The customer reported: the surgeon believes something is wrong with them. The doctor feels like the instruments are no longer accurate. They were checked with conventional means im and the varus/valgus was off.
 
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Brand NameKNEEALIGN 2 INSTRUMENT SET
Type of DeviceMICROBLOCK
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
9202546370
MDR Report Key8167633
MDR Text Key130478238
Report Number3007521480-2018-00003
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K162962
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 06/09/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/15/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number402042
Device Catalogue Number402043
Device Lot NumberT11112301Z
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/30/2018
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/15/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/23/2011
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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