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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SàRL CH 5.5 EXP VERSE UNITIZED SET SCR ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

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MEDOS INTERNATIONAL SàRL CH 5.5 EXP VERSE UNITIZED SET SCR ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD Back to Search Results
Catalog Number 199721001S
Device Problem Crack (1135)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/20/2020
Event Type  malfunction  
Manufacturer Narrative
A product investigation was completed: upon visual inspection, the most distal thread was observed to be peeling. No other issues were identified with the returned device. The relevant drawings were reviewed. The complaint condition is confirmed. There is no indication that a design or manufacturing issue has caused the issue and hence the root cause cannot be determined. Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed. Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities. 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 (b)(6) reports an event as follows: it was reported during a pelvic fusion in the iliac treating pelvic fracture on (b)(6) 2020 the inner setscrew (silver) went deeper than expected during final fixation. When the inner setscrew was removed, it appeared that the outer setscrew had been cross threaded. The surgeon tried two unitized setscrews as replacements, which both failed. When other setscrew was replaced, it was fixed to a certain extent. So, the surgeon lightly tightened this final replacement without torque-applied final fixation. The procedure was completed without surgical delay. The patient outcome was reported as stable. Concomitant device reported: verse screw (part 199721000s, lot unknown, quantity 1); rod (part unknown, lot unknown, quantity 1); unitized setscrews (part 199721001s, lot wf1232, quantity 2). This report is for a unitized setscrew. This is report 4 of 4 for (b)(4).
 
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Brand Name5.5 EXP VERSE UNITIZED SET SCR
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)
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 Key9861148
MDR Text Key197818027
Report Number1526439-2020-00741
Device Sequence Number1
Product Code NKB
UDI-Device Identifier10705034466149
UDI-Public(01)10705034466149
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K142185
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 01/20/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/20/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number199721001S
Device Lot NumberWF1232
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/06/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/18/2020
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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