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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SàRL CH MIS SINGLE INNER SETSCW ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

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MEDOS INTERNATIONAL SàRL CH MIS SINGLE INNER SETSCW ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE Back to Search Results
Model Number 179702000
Device Problem Device Slipped (1584)
Patient Problems Injury (2348); No Code Available (3191); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Manufacturer Narrative

Additional device product codes: kwp; kwq; mnh; mni; osh. Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. (b)(4). 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

Device report from synthes reports an event in (b)(6) as follows: it was reported that the patient was treated with an instrumentation from th11 to l1 with uss mis few years ago. On (b)(6) 2020 the instrumentation was continued from l2 to s1. On (b)(6) 2020 the patient fell while exiting the hospital bed. X-raystaken revealed that both expedium rods have been dislocated. Furthermore it was suspected that both expedium innies in s1 had come loose. The revision surgery was performed on (b)(6) 2020 and innies at l4/l5 and s1 were removed from both sides of the rods and replaced. The same rod was used. The 6. 0 screws in s1 were replaced with 7. 0 screws. It is unknown if 2x viper cfx 6,0, or 2x viper 6,0 have been removed. Patient outcome is reported as stable. Concomitant device reported: viper cfx 6. 0 (part# unknown, lot# unknown, quantity 2); viper 6. 0 (part# unknown, lot# unknown, quantity 2); single innie inserter (part# 279702000, lot# unknown, quantity unknown); single-inner setscrew (part # 179702000, lot # avcffh, quantity 3); single-inner setscrew (part # 179702000, lot # 257617, quantity 1); single-inner setscrew (part # 179702000, lot # unknown, quantity 1); expedium 5. 5 ti z-rod 300mm (part # 179798300, lot # ti0884, quantity 1), rod (part # unknown, lot # unknown, quantity 1). This report is for one (1) single-inner setscrew. This is report 5 of 8 for complaint (b)(4).

 
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Brand NameMIS SINGLE INNER SETSCW
Type of DeviceORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
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 02400
SZ 02400
Manufacturer Contact
kara ditty-bovard
325 paramount drive
raynham, MA 02767
6103142063
MDR Report Key10613946
MDR Text Key209647009
Report Number1526439-2020-01852
Device Sequence Number1
Product Code NKB
Combination Product (Y/N)N
Reporter Country CodeGM
PMA/PMN NumberK160904
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 09/08/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/01/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number179702000
Device Catalogue Number186715000
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/08/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/04/2021
Was Device Evaluated By Manufacturer? Yes
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: 10/01/2020 Patient Sequence Number: 1
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