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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SàRL CH VERSE CORRECTION KEY THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

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MEDOS INTERNATIONAL SàRL CH VERSE CORRECTION KEY THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Model Number 199721000
Device Problems Break (1069); Crack (1135)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/23/2021
Event Type  malfunction  
Manufacturer Narrative
Additional procodes: kwp, kwq, mnh, mni, osh. Reporter is a synthes employee. The device history record (dhr) of product code: 199721000, lot: 290277 was electronically reviewed and no non-conformances were observed during the manufacturing process. The product was released on: october 13, 2020. Visual inspection: the verse correction key was returned and received at us customer quality (cq). Upon visual inspection, the distal threads of the poly lock (p/n: p/n: 887010007) were observed to be peeled and broken and the broken threads were not returned. There were scratches on the device but have no impact on the device functionality. No other issues were observed with the returned device. Functional test: functional test cannot be performed as the device was returned by itself. However, the broken threads would have contributed to the complaint condition. Dimensional inspection: a dimensional inspection was not performed due to post manufacturing damage. Document/specification review: based on the date of manufacture, the current and manufactured revision of drawings were reviewed. Expedium verse - dual lock assembly investigation conclusion the complaint condition is confirmed for the verse correction key. There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined. The potential cause could be due to unintended forces applied to the device. 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 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 austria reports an event as follows: it was reported that during a scoliosis procedure on (b)(6) 2021, when inserting the correction key, (2) of them tilted. (1) screw was fixed with the unitized set screw and the other screw was not fixed at all. There was a (15) minutes surgical delay due to the reported event. The procedure was successfully completed. No patient consequences reported. This report is for a verse correction key. This is report 2 of 3 for (b)(4).
 
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Brand NameVERSE CORRECTION KEY
Type of DeviceTHORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
Manufacturer (Section D)
MEDOS INTERNATIONAL SàRL CH
chemin-blanc 38
le locle 02400
SZ 02400
Manufacturer (Section G)
MEDOS INT SPINE
chemin blanc 38
le locle
SZ
Manufacturer Contact
kara ditty-bovard
chemin-blanc 38
le locle 
SZ  
6103142063
MDR Report Key11938560
MDR Text Key258294117
Report Number1526439-2021-01098
Device Sequence Number1
Product Code NKB
UDI-Device Identifier10705034466132
UDI-Public(01)10705034466132
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
K142185
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
Report Date 03/23/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/04/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number199721000
Device Catalogue Number199721000
Device Lot Number290277
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/28/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/13/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/13/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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