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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SàRL CH CORTICAL FIX X-TAB 7X40MM TI ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

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MEDOS INTERNATIONAL SàRL CH CORTICAL FIX X-TAB 7X40MM TI ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD Back to Search Results
Model Number 186770140
Device Problem Device Slipped (1584)
Patient Problem Osteolysis (2377)
Event Type  Injury  
Manufacturer Narrative

Product complaint #(b)(4). Additional product code: kwp;kwq;mnh;mni;osh. Complainant part is not expected to be returned for manufacturer review /investigation. The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report. The product was not returned. Based on the information available, it has been determined that no corrective and 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 history lot a review of the receiving inspection (ri) for cortical fix x-tab 7x40mm ti was conducted identifying that lot number tbshw was released in a single batch. Batch1: lot qty of (b)(4) units were released on 23 aug 2017 with no discrepancies. As a result, the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer. Device history review: the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer. 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 on an unknown date that the patient underwent for revision procedure (l3-s) due to suffered from asd at l3. When the revision procedure (l3-s) was performed, screw loosening was revealed, which was replaced with a new screw. It was unknown if the revision surgery completed successfully. The patient outcome was unknown. The primary olif and tlif (l3-sai) were performed on (b)(6) 2019. This complaint involves seven (7) devices. This report is for (1) cortical fix x-tab 7x40mm ti this report is 5 of 7 for (b)(4).

 
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Brand NameCORTICAL FIX X-TAB 7X40MM TI
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 Key12320416
MDR Text Key266501240
Report Number1526439-2021-01688
Device Sequence Number1
Product Code NKB
Combination Product (Y/N)N
Reporter Country CodeJA
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
Report Date 07/15/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/13/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number186770140
Device Catalogue Number186770140
Device LOT NumberTBSHW
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 Received07/15/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/11/2017
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: 08/13/2021 Patient Sequence Number: 1
Treatment
5.5 TI CORT FIX 8X45MM; 5.5 TI CORT FIX 8X45MM; CORTICAL FIX X-TAB 7X45MM TI; CORTICAL FIX X-TAB 7X45MM TI; CORTICAL FIX X-TAB 7X45MM TI; VIPER TI SAI POLY 9X80MM
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