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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SàRL CH EXP TI POLY SCREW 8MMX70MM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

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MEDOS INTERNATIONAL SàRL CH EXP TI POLY SCREW 8MMX70MM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Model Number 179712870
Device Problems Break (1069); Entrapment of Device (1212)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/10/2021
Event Type  Malfunction  
Manufacturer Narrative

Additional procodes: kwp, kwq, mnh, mni. Complainant part is not expected to be returned for manufacturer review/investigation. The investigation could not be completed; no conclusion could be drawn, as no product was received. 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.

 
Event Description

Device report from (b)(6) reports an event as follows: it was reported that patient underwent surgery on (b)(6) 2021. During surgery, two pelvic screws were planned to be inserted but doctor had issues with both. One screw head broke, and the doctor could not remove the screw from the pelvis but was able to remove the other one. The removed screw was discarded. New screws were implanted. Checking the or images confirmed that an expedium pelvic screw with broken screw head was inside the patient. The procedure was completed successfully with a thirty to forty-five (30-45) minute delay. This report is for an expedium titanium (ti) poly screw 8mmx70mm. This is report 1 of 2 for (b)(4).

 
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Brand NameEXP TI POLY SCREW 8MMX70MM
Type of DeviceTHORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
Manufacturer (Section D)
MEDOS INTERNATIONAL SàRL CH
chemin-blanc 38
le locle 02400
SZ 02400
Manufacturer (Section G)
BRIDGEWATER DISTRIBUTION
50 scotland boulevard
bridgewater MA 02324
Manufacturer Contact
kara ditty-bovard
chemin-blanc 38
le locle 
SZ  
6103142063
MDR Report Key11633651
MDR Text Key244407723
Report Number1526439-2021-00655
Device Sequence Number1
Product Code NKB
Combination Product (Y/N)N
Reporter Country CodeEN
PMA/PMN NumberK160904
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 03/11/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/08/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number179712870
Device Catalogue Number179712870
Device LOT NumberRL286837
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 Received04/21/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/15/2020
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 04/08/2021 Patient Sequence Number: 1
Treatment
EXP TI POLY SCREW 8MMX70MM; UNKNOWN SCREWDRIVERS
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