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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORTHALIGN, INC. IMPACTOR ADAPTER- S/B

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ORTHALIGN, INC. IMPACTOR ADAPTER- S/B Back to Search Results
Model Number 403028
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hip Fracture (2349); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/23/2020
Event Type  Injury  
Manufacturer Narrative
The reported inability to disassemble the cup will be investigated once the product is returned. Orthalign is filing this mdr in an abundance of caution due to the outcome of this case and the potential connection to the hipalign system.
 
Event Description
It was reported that total hip arthroplasty was performed with hipalign. After cup impaction with 48mm cup, the surgeon tried to disengage from cup and impactor. However, he was unable to disassemble the cup. Subsequently, two surgeons disengaged the cup with force. The patient acetabular was little damaged by disassembly so bigger cup (50mm) was used to complete the procedure.
 
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Brand NameIMPACTOR ADAPTER- S/B
Type of DeviceIMPACTOR ADAPTER
Manufacturer (Section D)
ORTHALIGN, INC.
120 columbia
suite 500
aliso viejo, ca
Manufacturer (Section G)
ORTHALIGN, INC.
120 columbia
suite 500
aliso viejo, ca
Manufacturer Contact
karyl haskel
120 columbia
suite 500
aliso viejo, ca 
MDR Report Key10377134
MDR Text Key202003507
Report Number3007521480-2020-00010
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 company representative,distri
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 06/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/06/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number403028
Device Catalogue Number403028
Device Lot Number10808VZ
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/28/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/06/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/23/2018
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: 08/06/2020 Patient Sequence Number: 1
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