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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG ORTHOPILOT BASIS COMPACT ORTHOPILOT NAVIGATION SYSTEM

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AESCULAP AG ORTHOPILOT BASIS COMPACT ORTHOPILOT NAVIGATION SYSTEM Back to Search Results
Model Number FS101
Device Problem Compatibility Problem (2960)
Patient Problem Unspecified Infection (1930)
Event Date 11/26/2019
Event Type  Injury  
Manufacturer Narrative
Manufacturing site evaluation: investigation on-going. Additional information / investigation results will be provided in a supplemental report.
 
Event Description
It was reported that there was an issue with orthopilot basis. Following customer information was reported: study: (b)(6). The implantation was on (b)(6) 2019. Postoperative (po) suspicion of early infection. Therapeutic measures: puncture, anticoagulation therapy, pt, medication. An additional medical intervention was necessary. Additional information was not provided nor available. Additional patient information is not available. The adverse event is filed under (b)(4). Involved components: nx057k - vega ps tibial plateau cemented t4 - 52360588a, nx140 - vega ps gliding surface t4/4+ 10mm - 52421371, nx033k - vega ps femoral component cemented f6n r - 52530600.
 
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Brand NameORTHOPILOT BASIS COMPACT
Type of DeviceORTHOPILOT NAVIGATION SYSTEM
Manufacturer (Section D)
AESCULAP AG
po box 40
tuttlingen, 78501
GM 78501
Manufacturer (Section G)
AESCULAP AG
po box 40
tuttlingen, 78501
GM 78501
Manufacturer Contact
kerstin rothweiler
po box 40
tuttlingen, 78501
GM   78501
MDR Report Key9728660
MDR Text Key182298452
Report Number9610612-2019-00953
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K080547
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/19/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberFS101
Device Catalogue NumberFS101
Device Lot Number51589952
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/19/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/05/2009
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 02/19/2020 Patient Sequence Number: 1
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