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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SàRL CH MIS SINGLE INNER SETSCW; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
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MEDOS INTERNATIONAL SàRL CH MIS SINGLE INNER SETSCW; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Model Number 186715000
Device Problem Migration (4003)
Patient Problem No Code Available (3191)
Event Date 10/26/2020
Event Type  Injury  
Manufacturer Narrative
Additional product code kwp; kwq; mnh; mni; osh.(b)(4).The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report 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 on (b)(6) 2020, the patient underwent for a revision surgery.The patient had posterior lumbar interbody fusion (plif) at l3/iliac treating tumor in the sacrum spine on (b)(6) 2020.It was found that on (b)(6) 2020, the rod had come off and setscrews are displaced.It was unknown if the revision surgery successfully completed.The patient outcome was unknown.This complaint involves four (4) devices.This report is for (1) mis single inner setscrew.This is report 2 of 4 for (b)(4).
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H3, h4, h6: since xray/ct scan was not provided, the complaint condition for migration/back out/pull-out cannot be confirmed.There is no indication that a design or manufacturing issue has caused the issue.The root cause could not be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot = the dhr of product code 186715000, lot 272814, was reviewed and no non-conformance was observed during the manufacturing process.The product was released on february 12, 2020.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.
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: h11: corrected data.H4: manufacturing date.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.Manufacturing date.
 
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Brand Name
MIS SINGLE INNER SETSCW
Type of Device
THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
Manufacturer (Section D)
MEDOS INTERNATIONAL SàRL CH
chemin-blanc 38
le locle 02400
SZ  02400
MDR Report Key10868742
MDR Text Key217178982
Report Number1526439-2020-02235
Device Sequence Number1
Product Code NKB
UDI-Device Identifier10705034121192
UDI-Public10705034121192
Combination Product (y/n)N
PMA/PMN Number
K160904
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 10/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/19/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number186715000
Device Catalogue Number186715000
Device Lot Number272814
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/17/2020
Date Manufacturer Received12/29/2020
Patient Sequence Number1
Treatment
5.5 EXP VERSE UNITIZED SET SCR.; MIS SINGLE INNER SETSCW.; UNKNOWN RODS.; 5.5 EXP VERSE UNITIZED SET SCR; MIS SINGLE INNER SETSCW; UNKNOWN RODS
Patient Outcome(s) Required Intervention;
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