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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORTHALIGN INC. UNIALIGN KNEEALIGN 2 INSTRUMENT KIT

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ORTHALIGN INC. UNIALIGN KNEEALIGN 2 INSTRUMENT KIT Back to Search Results
Model Number 402064
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Bone Fracture(s) (1870)
Event Type  Injury  
Manufacturer Narrative
In the month of january (2019) orthalign, inc. Was made aware of 6 patients who underwent unicompartmental knee arthroplasty surgery that utilized orthalign inc. 's orthalign plus®, unialign¿ system performed by dr. (b)(6) of (b)(6) in (b)(6). These six patients were discovered to have induced tibial plateau fractures at post-operative appointments. Once orthalign was made aware of these cases dr. (b)(6) was immediately contacted to gather more information. Through investigating these six incidences orthalign cannot verify the initial complaint regarding the kneealign® 2 instrumentation. A risk assessment was performed, and internal risk documents were reviewed. The known risk of bone fractures in unicompartmental knee arthroplasty's is addressed specific to pin placement. The placement of pins per the instrumentation instruction has been assessed and validated by surgeons. Through the third-party investigation performed with dr. (b)(6), orthalign gathered the following information: no noted device defects or malfunctions were detected. The orthalign instruments performed as expected. The instruments have also been used in other cases without any problems. The unialign instruments were used with the orthalign plus unit and ka2 instruments set per standard procedure. The surgeon fixated the instrumentation appropriately. No notable intraoperative challenges and observations were detected during the case. No complicating factors were observed. No other relevant patient history or medical conditions was noted. Patient x-rays and two images from one of the cases were received. Fractures propagated at the plateau base, but not from where pins were placed. There is no known cause of the tibial fractures and no immediate device related cause or contribution to these events. Orthalign is filing this mdr in an abundance of caution due to the outcome of these cases and the potential connection to the unialign¿ system.
 
Event Description
Orthalign employee reported: placement of pins through multiple holes in ka2 tibial jig arm and/or in uni medial cutting block are believed to have induced a tibial plateau fracture.
 
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Brand NameUNIALIGN
Type of DeviceKNEEALIGN 2 INSTRUMENT KIT
Manufacturer (Section D)
ORTHALIGN INC.
120 columbia
suite 500
aliso viejo CA 92656
Manufacturer Contact
katy nennig
120 columbia
suite 500
aliso viejo, CA 92656
9202546370
MDR Report Key8333599
MDR Text Key136142806
Report Number3007521480-2019-00006
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K163379
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 02/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/12/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number402064
Device Catalogue Number402064
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/24/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 02/12/2019 Patient Sequence Number: 1
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