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U.S. Department of Health and Human Services

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

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ORTHALIGN, INC. KNEEALIGN 2 MICROBLOCK ASSEMBLY Back to Search Results
Model Number 402042
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Joint Laxity (4526)
Event Date 01/15/2020
Event Type  Injury  
Manufacturer Narrative
An investigation of the femoral cutting block, distal paddle, and microblock was performed. The cutting block was able to be assembled to the returned microblock without any issue. There were no issues observed during a fit check of all three mechanical instruments. No issues were observed with the distal paddle. No issues were observed with the microblock. No issues were observed with the femoral cutting block. 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, inc. Will continue to monitor this issue and take action if alert limits are exceeded. This initial report is being filed after the due date as the initial submission was found to have not be received during an attempt to submit the follow-up report. At that time, the error message "error: initial report / prior supplement has not been received. The initial report is missing. " alerted orthalign inc of the issue prompting the submission of this as an initial report.
 
Event Description
It was reported that total knee arthroplasty was performed with kneealign. Femoral distal cut was supposed to be 9mm but the femoral bone was actually cut about 15mm.
 
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Brand NameKNEEALIGN 2
Type of DeviceMICROBLOCK ASSEMBLY
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 Key12099232
MDR Text Key263873296
Report Number3007521480-2021-00014
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K172462
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 06/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/01/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number402042
Device Catalogue Number402042
Device Lot Number12050101Z
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/02/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/31/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/07/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 07/01/2021 Patient Sequence Number: 1
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