Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SàRL CH VERSE CORRECTION KEY; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDOS INTERNATIONAL SàRL CH VERSE CORRECTION KEY; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE Back to Search Results
Model Number 199721000
Device Problem Break (1069)
Patient Problems Failure of Implant (1924); Spinal Column Injury (2081); No Code Available (3191)
Event Date 01/01/2018
Event Type  Injury  
Manufacturer Narrative
Event occurred on an unknown date in 2018.Additional procode: kwp;kwq;mnh;mni;osh.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(4).The investigation could not be completed; no conclusion could be drawn, as no product was received.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)(6) as follows: it was reported that the verse advanced screws broke in the vertebral body post-operation.There is no further information available.Concomitant device reported: verse correction key (part# 199721000 , lot# 206919, quantity 1); verse correction key (part# 199721000 , lot# 196158, quantity 1); verse correction key (part# 199721000 , lot# 190651, quantity 1); verse correction key (part# 199721000 , lot# 190159, quantity 1); 5.5 exp verse fen scr 6.0x45 (part# 199723645, lot# 155845, quantity 1); 5.5 exp verse fen scr 6.0x45 (part# 199723645, lot# 184191, quantity 1); 5.5 exp verse fen scr 6.0x45 (part# 199723645, lot# 175103, quantity 1); 5.5 exp verse fen scr 6.0x45 (part# 199723645, lot# 184192, quantity 1).This report is for one (1) verse correction key.This is report 6 of 8 for (b)(4).
 
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.H11: correct data: g4: awareness date reported on initial report as december 03, 2018 but should have been september 22, 2020.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.
 
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.H10 additional narrative: updated data: d4, d10, h3, h4, h6.Investigation summary: visual inspection: the verse correction key (part #: 199721000, lot #: 190159) was received at us customer quality (cq).The visual inspection performed on the returned device did not reveal any damage.Device failure/defect identified? no.Dimensional inspection: drawing: dwg-887010007 rev b.Specifications: major diameter: measured: major diameter : conform.Device used: hand micrometer om521.Document/specification review: the following drawings were reviewed dwg-887010006 rev e (current and manufactured to) - expedium verse dual lock assembly; dwg-887010007 rev b (current and manufactured to) - expedium verse dual lock poly lock; dwg-887010008 rev b (current and manufactured to) - expedium verse dual lock rod lock; no design issues or discrepancies were identified.Complaint confirmed? no.Investigation conclusion: this complaint is not confirmed as the complaint device, verse correction key (part #: 199721000, lot #: 190159) was inspected and there was no issue reported.No definitive root cause could be determined based on the information provided.No new, unique or different patient harms were identified as a result of this evaluation.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings, it has been determined that no corrective and/or preventive action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot; the dhr of product code: 199721000; lot : 196158; was electronically reviewed and no non-conformances; were observed during the manufacturing process.The product was released on: may 8, 2018.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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
VERSE CORRECTION KEY
Type of Device
ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
Manufacturer (Section D)
MEDOS INTERNATIONAL SàRL CH
chemin-blanc 38
le locle 02400
SZ  02400
MDR Report Key10581195
MDR Text Key208371091
Report Number1526439-2020-01783
Device Sequence Number1
Product Code NKB
UDI-Device Identifier10705034466132
UDI-Public(01)10705034466132
Combination Product (y/n)N
PMA/PMN Number
K142185
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup,Followup
Report Date 12/03/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/24/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number199721000
Device Catalogue Number199721000
Device Lot Number196158
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/22/2020
Date Manufacturer Received09/22/2020
Patient Sequence Number1
Treatment
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; VERSE CORRECTION KEY; VERSE CORRECTION KEY; VERSE CORRECTION KEY; 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; VERSE CORRECTION KEY; VERSE CORRECTION KEY; VERSE CORRECTION KEY
Patient Outcome(s) Required Intervention;
-
-