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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SàRL CH UNIVERSAL NAVIGATION ADAPTOR SET NAVIGATION RING DIAMETER 12 - ST ORTHOPEDIC STEREOTAXIC INSTRUMENT

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MEDOS INTERNATIONAL SàRL CH UNIVERSAL NAVIGATION ADAPTOR SET NAVIGATION RING DIAMETER 12 - ST ORTHOPEDIC STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 302022012
Device Problems Break (1069); Entrapment of Device (1212); Mechanical Jam (2983)
Patient Problem Foreign Body In Patient (2687)
Event Date 11/25/2021
Event Type  Injury  
Event Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that during a navigated symphony surgery, the screw which connects the universal navigation adaptor set (unas) ring with the stern broke. The screw jammed and broke while trying to unscrew it. It was noted that fragments were generated when the screw broke and those fragments were retained in the patient. The procedure was completed successfully with no delay. This report is for a universal navigation adaptor set (unas) ring. This is report 1 of 1 for (b)(4).
 
Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. Initial reporter is a depuysynthes sales representative. Without a lot number the device history records review could not be completed. Product was not returned. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
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Brand NameUNIVERSAL NAVIGATION ADAPTOR SET NAVIGATION RING DIAMETER 12 - ST
Type of DeviceORTHOPEDIC STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
MEDOS INTERNATIONAL SàRL CH
chemin-blanc 38
le locle 02400
SZ 02400
Manufacturer (Section G)
SENTIO (INNOVATIVE SURGICAL SOLUTIONS, LLC)
50461 west pontiac trail
wixom MI 48393
Manufacturer Contact
kara ditty-bovard
325 paramount drive
raynham, MA 02767
6103142063
MDR Report Key13046475
MDR Text Key285170562
Report Number1526439-2021-02597
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K191943
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup,Followup
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received12/20/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number302022012
Device Catalogue Number302022012
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/07/2022
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: 12/20/2021 Patient Sequence Number: 1
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