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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SàRL CH EXPEDIUM VERSE SPINE SYSTEM UNITIZED SET SCREW 5.5 ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

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MEDOS INTERNATIONAL SàRL CH EXPEDIUM VERSE SPINE SYSTEM UNITIZED SET SCREW 5.5 ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE Back to Search Results
Model Number 199721001
Device Problem Device Slipped (1584)
Patient Problem Pain (1994)
Event Type  Injury  
Manufacturer Narrative

Additional narrative: additional device product codes: kwp, osh, mni, kwq and mnh. The device has been received, the investigation is in progress, 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

Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, the patient¿s rod broke post-op. The patient received the implants in (b)(6) 2020. The patient underwent a revision surgery due to pain on (b)(6) 2021. A broken rod was found on the left side of the construct and at the top of the construct, on the right side, a dislodged screw from l1 was found. Both the rod and screw were replaced in the revision surgery. This report involves one (1) expedium verse spine system unitized set screw 5. 5. This is report 1 of 2 for (b)(4).

 
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Brand NameEXPEDIUM VERSE SPINE SYSTEM UNITIZED SET SCREW 5.5
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)
SENTIO (INNOVATIVE SURGICAL SOLUTIONS, LLC)
50461 west pontiac trail
wixom MI 48393
Manufacturer Contact
kara ditty-bovard
chemin-blanc 38
le locle 02400
SZ   02400
6103142063
MDR Report Key12376961
MDR Text Key268451116
Report Number1526439-2021-01790
Device Sequence Number1
Product Code NKB
Combination Product (Y/N)N
Reporter Country CodeAS
PMA/PMN NumberK142185
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 07/30/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/27/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number199721001
Device Catalogue Number199721001
Device LOT NumberWM3131
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/18/2021
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/15/2021
Was Device Evaluated By Manufacturer? No
Date Device Manufactured03/12/2019
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: 08/27/2021 Patient Sequence Number: 1
Treatment
ROD, 480 MM; UNKNOWN SCREWS
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