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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SàRL CH UNKNOWN RODS ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

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MEDOS INTERNATIONAL SàRL CH UNKNOWN RODS ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD Back to Search Results
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)
Patient Problems Pain (1994); Osteolysis (2377)
Event Type  Injury  
Manufacturer Narrative
This report is for an unk rods/unknown lot. Part and lot number are unknown. Without the specific part number; the udi number and 510-k 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
Device report from synthes reports an event in (b)(4) as follows: it was reported that, procedure was revised due to back pain and connection degeneration. This report is for one (1) unk rods. This is report 3 of 7 for complaint (b)(4).
 
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Brand NameUNKNOWN RODS
Type of DeviceORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
Manufacturer (Section D)
MEDOS INTERNATIONAL SàRL CH
chemin-blanc 38
le locle 02400
SZ 02400
Manufacturer (Section G)
SENTIO (INNOVATIVE SURGICAL SOLUTIONS, LLC)
50461 west pontiac trail
wixom MI 48393
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key12962001
MDR Text Key286449812
Report Number1526439-2021-02525
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/08/2021
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
Date Manufacturer Received12/13/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 12/08/2021 Patient Sequence Number: 1
Treatment
5.5 TI CORT FIX 7X40MM; SI POLYAXL SCREW 7 X 45MM; SI POLYAXL SCREW 7 X 45MM; SI POLYAXL SCREW 7 X 50MM; UNKNOWN CAGE/SPACER; UNKNOWN LOCKING/SET SCREWS; UNKNOWN RODS; UNKNOWN SCREWS
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