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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 5X25MM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

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MEDOS INTERNATIONAL SàRL CH 5.5 TI CORT FIX 5X25MM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE Back to Search Results
Model Number 186731525
Device Problem Disconnection (1171)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/01/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Device is available for evaluation. Investigation will be conducted. Follow up will be filed with the investigation results. 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 the posterior thoracic fusion surgery was performed on (b)(6) 2019 due to nerve compression due to malignant spine metastasis. During the surgery, after the surgeon implanted the screw into patient¿s thoracic spine, when the surgeon tried to implant the rod (p/n and lot# were unknown), it was reported that the surgeon recognized that the collet part at the screw head was twisted and broken. The implanted screw was revised to alternative screw, and completed the surgery. There was no information of surgical delay and there was no adverse consequence to the patient. No further information was provided by the hospital.
 
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Brand Name5.5 TI CORT FIX 5X25MM
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
SZ
Manufacturer Contact
kara ditty-bovard
325 paramount drive
raynham, MA 02767
6103142063
MDR Report Key8550028
MDR Text Key144569727
Report Number1526439-2019-51560
Device Sequence Number1
Product Code NKB
UDI-Device Identifier10705034351599
UDI-Public(01)10705034351599
Combination Product (y/n)N
PMA/PMN Number
K110216
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,Followup
Report Date 04/01/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/25/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number186731525
Device Catalogue Number186731525
Device Lot NumberATCCBL
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 Received06/27/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/12/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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