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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SàRL CH VIPER SYSTEM POLYAXIAL WIDE LAG SCREW 5.5 8 X 80MM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

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MEDOS INTERNATIONAL SàRL CH VIPER SYSTEM POLYAXIAL WIDE LAG SCREW 5.5 8 X 80MM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD Back to Search Results
Model Number 179704880
Device Problems Break (1069); Entrapment of Device (1212)
Patient Problem Foreign Body In Patient (2687)
Event Date 01/01/2021
Event Type  Injury  
Event Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, the viper system wide lag screw implanted in the patient broke at the transition between the smooth and threaded portion of the screw. The original surgery took place in 2018. The patient underwent revision surgery on (b)(6) 2021. Upon removal, only the smooth part of the screw shank could be retrieved and the proximal threaded tip of the screw was left in the ilium. An iliac bolt was used to revise the construct. This report is for one (1) viper system polyaxial wide lag screw 5. 5 8 x 80mm. This is report 1 of 1 for (b)(4).
 
Manufacturer Narrative
Additional narrative: event occurred on an unknown date in 2021. Additional procode: mnh, mni, kwp. The device was 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.
 
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Brand NameVIPER SYSTEM POLYAXIAL WIDE LAG SCREW 5.5 8 X 80MM
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
chemin-blanc 38
le locle 02400
SZ   02400
6103142063
MDR Report Key13003716
MDR Text Key285170365
Report Number1526439-2021-02546
Device Sequence Number1
Product Code NKB
UDI-Device Identifier10705034265728
UDI-Public10705034265728
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K111571
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/14/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number179704880
Device Catalogue Number179704880
Device Lot NumberTBTWW
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/06/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/30/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/15/2018
Is the Device Single Use? Yes
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 12/14/2021 Patient Sequence Number: 1
Treatment
UNKNOWN EXTRACTION INSTRUMENTS
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