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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SàRL CH 5.5 EXP VERSE DI SET SCR; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

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MEDOS INTERNATIONAL SàRL CH 5.5 EXP VERSE DI SET SCR; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Model Number 199721000S
Device Problem Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/05/2022
Event Type  malfunction  
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.A manufacturing record evaluation was performed for the finished device product code: 199721000s.Lot: 325796.It was electronically reviewed and no non-conformance's / manufacturing irregularities were identified during the manufacturing process.The product was released on: september 30, 2021.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the threads of the reported 5.5 exp verse di set scr appear to be stripped.The poly rod appears to have damage attributable to the extraction process.No other problems identified.A dimensional inspection was unable to be performed due to device design.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces as mentioned in the event description.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the 5.5 exp verse di set scr would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot 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.Drawing/specifications reviewed current and manufactured revisions were reviewed.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 synthes reports an event in the (b)(6) as follows: it was reported that patient underwent an ileum procedure on (b)(6) 2022.When the surgeon tried to apply torque to a correction key, the setscrew¿s threads became stripped.Next, the replacing setscrew was placed for torque application, which resulted in another of the same event.Finally, the surgeon replaced a screw, applied torque and completed the rest of the procedure.The patient was x-rayed, and it was confirmed that no fragment had been left in the lesion.Procedure was completed successfully with less than thirty minutes delay.Patient was stable.This report is for a 5.5 exp verse di set scr.This is report 3 of 3 for (b)(4).
 
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Brand Name
5.5 EXP VERSE DI SET SCR
Type of Device
THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
Manufacturer (Section D)
MEDOS INTERNATIONAL SàRL CH
chemin-blanc 38
le locle 02400
SZ  02400
Manufacturer Contact
kate karberg
chemin-blanc 38
le locle 
SZ  
3035526892
MDR Report Key14843879
MDR Text Key303071765
Report Number1526439-2022-00958
Device Sequence Number1
Product Code NKB
UDI-Device Identifier10705034466125
UDI-Public(01)10705034466125
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K142185
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number199721000S
Device Catalogue Number199721000S
Device Lot Number325796
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/26/2022
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/02/2022
Initial Date FDA Received06/28/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/30/2021
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
5.5 EXP VERSE CAN SCR 8.0X90; 5.5 EXP VERSE CAN SCR 8.0X90; 5.5 EXP VERSE DI SET SCR
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