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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SàRL CH 5.5 TI CORT FIX 7X45MM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

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MEDOS INTERNATIONAL SàRL CH 5.5 TI CORT FIX 7X45MM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD Back to Search Results
Model Number 186731745
Device Problem Device Slipped (1584)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Manufacturer Narrative

Product complaint #(b)(4). Additional narrative: additional product code: kwp;kwq;mnh;mni. Complainant part is expected to be returned for manufacturer review/ investigation but has yet to be received. Without a lot number, the device history records review could not be completed as no product was received. The investigation could not be completed, no product was received; 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

It was reported that on an unknown date, the patient had a surgery for posterior spinal fusion in (b)(6) 2020. At a follow up appointment in (b)(6) 2020, xray images showed that the set screw had loosened from the sai screws bilaterally and the rod had loosened due to head splay. The s1 and l5 screws had fractured at the neck of the screw just below the tulip. It is unknown if fragments were generated. The patient did not achieve a fusion below l5 due to this hardware failure. Procedure outcome is unknown. This complaint involves five (5) devices. This report is for (1) 5. 5 ti cort fix 7x45mm. This report is 4 of 5 for (b)(4).

 
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Brand Name5.5 TI CORT FIX 7X45MM
Type of DeviceORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
Manufacturer (Section D)
MEDOS INTERNATIONAL SàRL CH
chemin-blanc 38
le locle 02400
SZ 02400
Manufacturer Contact
kara ditty-bovard
325 paramount drive
raynham, MA 02767
6103142063
MDR Report Key12354209
MDR Text Key267685234
Report Number1526439-2021-01749
Device Sequence Number1
Product Code NKB
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK160904
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/27/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/23/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number186731745
Device Catalogue Number186731745
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 Received09/24/2021
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

Patient TREATMENT DATA
Date Received: 08/23/2021 Patient Sequence Number: 1
Treatment
5.5 TI CORT FIX 7X45MM; 5.5 TI CORT FIX 7X45MM; VIPER TI SAI POLY 9X100MM; VIPER TI SAI POLY 9X90MM
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