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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SàRL CH 5.5 EXP VERSE FEN SCR 6.0X45; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
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MEDOS INTERNATIONAL SàRL CH 5.5 EXP VERSE FEN SCR 6.0X45; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Model Number 199723645S
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code Pain (1994)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
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.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, both s1 screws appeared to have fractured at the top of the shank.This was discovered four (4) weeks after the initial procedure.The patient reported pain around the site.A revision procedure to revise the construct is scheduled on an unknown date.No further information provided.This is report 5 of 10 for (b)(4).
 
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in 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 or Problem Description
Additional event information.Concomitant device reported: mmsi rod prebent, 5.5 x55mm, t(part# 179772055s , lot# unknown, quantity unknown ).5.5 exp verse fen scr 6.0x45 t(part# 199723645s, lot# unknown, quantity unknown ).This complaint involves eight (8) devices.
 
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Brand Name
5.5 EXP VERSE FEN SCR 6.0X45
Common Device Name
THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
Manufacturer (Section D)
MEDOS INTERNATIONAL SàRL CH
chemin-blanc 38
le locle 02400
SZ  02400
MDR Report Key11641667
Report Number1526439-2021-00664
Device Sequence Number11538062
Product Code NKB
UDI-Device Identifier10705034443515
UDI-Public(01)10705034443515
Combination Product (Y/N)N
Initial Reporter CountryUK
PMA/510(K) Number
K173095
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 03/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model Number199723645S
Device Catalogue Number199723645S
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 03/12/2021
Supplement Date Received by Manufacturer04/15/2021
Initial Report FDA Received Date04/09/2021
Supplement Report FDA Received Date05/07/2021
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
5.5 EXP VERSE FEN SCR 6.0X45; 5.5 EXP VERSE FEN SCR 6.0X45; 5.5 EXP VERSE FEN SCR 6.0X45; 5.5 EXP VERSE FEN SCR 6.0X45; 5.5 EXP VERSE UNITIZED SET SCR; 5.5 EXP VERSE UNITIZED SET SCR; 5.5 EXP VERSE UNITIZED SET SCR; 5.5 EXP VERSE UNITIZED SET SCR; 5.5 EXP VERSE UNITIZED SET SCR; MMSI ROD PREBENT, 5.5 X55MM, T; MMSI ROD PREBENT, 5.5 X55MM, T; UNKNOWN SCREWS; UNKNOWN SCREWS; 5.5 EXP VERSE FEN SCR 6.0X45; 5.5 EXP VERSE FEN SCR 6.0X45; 5.5 EXP VERSE FEN SCR 6.0X45; 5.5 EXP VERSE UNITIZED SET SCR; 5.5 EXP VERSE UNITIZED SET SCR; 5.5 EXP VERSE UNITIZED SET SCR; 5.5 EXP VERSE UNITIZED SET SCR; MMSI ROD PREBENT, 5.5 X55MM, T; UNKNOWN SCREWS; UNKNOWN SCREWS
Outcome Attributed to Adverse Event Required Intervention;
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