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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SàRL CH UNKNOWN SCREW/ROD CONSTRUCT ACCESSORIES THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

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MEDOS INTERNATIONAL SàRL CH UNKNOWN SCREW/ROD CONSTRUCT ACCESSORIES THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Perforation of Esophagus (2399); Unspecified Tissue Injury (4559)
Event Type  Injury  
Manufacturer Narrative
510k: this report is for an unknown screw/rod construct accessories/unknown lot. Part and lot numbers are unknown; udi number is unknown. Complainant part is not expected to be returned for manufacturer review/investigation. 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.
 
Event Description
The current report is a retrospective analysis of all 137 patients,all female with mean age of 69 years , data , prospectively collected in the swespine registry, for the period between january 02, 2006 and november 22,2020, and for the device(s) identified mountaineer instrumentation. 18 patients data who underwent posterior decompression/excision + instrumentation without graft was also prospectively collected in the swespine registry, for the same period wal also operated on with mountaineer instrumentation. Their mean age was 66 years (range 45-82). Females were 7 (39%). General complications-intraoperative complications: 3 dural tear. 2 oesophagus injury. General complications-postoperative complications within index hospitalization 2 pulmonary embolism. 2 venous thrombosis. 8 patients undergoing reintervention for a complication. 11 reinterventions for a complication. Readmissions 1: 1 adjustment of implant. 1 drain of deep infection. 1 removal of implant. 1 removal of intercorporal implant. 4 other. Readmissions 2: 1 drain of deep infection. 1 other. Readmissions 3: 1 removal of implant. Readmission ( for patients with metastatic malignancy) registered case which underwent re-instrumentation. This is for depuy spine mountaineer instrumentation. A copy of the clinical evaluation form is being submitted with this regulatory report.
 
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Brand NameUNKNOWN SCREW/ROD CONSTRUCT ACCESSORIES
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 02400
SZ   02400
6103142063
MDR Report Key12414946
MDR Text Key269579182
Report Number1526439-2021-01812
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeSW
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 08/04/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/02/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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 Received08/04/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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