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 UNKNOWN RODS; 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 UNKNOWN RODS; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE Back to Search Results
Device Problem Migration (4003)
Patient Problems Injury (2348); No Code Available (3191); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Manufacturer Narrative
This report is for an unknown rod/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).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.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 patient was treated with an instrumentation from th11 to l1 with uss mis few years ago.On (b)(6) 2020 the instrumentation was continued from l2 to s1.On (b)(6) 2020 the patient fell while exiting the hospital bed.X-raystaken revealed that both expedium rods have been dislocated.Furthermore it was suspected that both expedium innies in s1 had come loose.The revision surgery was performed on september 8, 2020 and innies at l4/l5 and s1 were removed from both sides of the rods and replaced.The same rod was used.The 6.0 screws in s1 were replaced with 7.0 screws.It is unknown if 2x viper cfx 6,0, or 2x viper 6,0 have been removed.Patient outcome is reported as stable.Concomitant device reported: viper cfx 6.0 (part# unknown, lot# unknown, quantity 2); viper 6.0 (part# unknown, lot# unknown, quantity 2); single innie inserter (part# 279702000, lot# unknown, quantity unknown); single-inner setscrew (part # 179702000, lot # avcffh, quantity 3); single-inner setscrew (part # 179702000, lot # 257617, quantity 1); single-inner setscrew (part # 179702000, lot # unknown, quantity 2); expedium 5.5 ti z-rod 300mm (part # 179798300, lot # ti0884, quantity 1).This report is for one (1) unknown rod.This is report 8 of 8 for complaint (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.H3, h6: product was not returned.Based on the information available, it has been determined that no corrective and 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.H6: codes updated.Health effect clinician code 2402 used to capture.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: 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
Updated event description: concomitant device reported: mis ti cfx fen poly 6x60 (part# 186727660, lot# 270052, quantity 1).Mis ti cfx fen poly 6x60 (part# 186727660, lot# 202353, quantity 1).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
UNKNOWN RODS
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 Key10614100
MDR Text Key209423738
Report Number1526439-2020-01855
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 09/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/01/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Date Manufacturer Received12/30/2020
Patient Sequence Number1
Treatment
MIS TI CFX FEN POLY 6X60; MIS TI CFX FEN POLY 6X60; SINGLE INNIE INSERTER; SINGLE-INNER SETSCREW; SINGLE-INNER SETSCREW; SINGLE-INNER SETSCREW; SINGLE-INNER SETSCREW; SINGLE-INNER SETSCREW; SINGLE-INNER SETSCREW; UNKNOWN SCREWS; UNKNOWN SCREWS; SINGLE INNIE INSERTER; SINGLE-INNER SETSCREW; SINGLE-INNER SETSCREW; SINGLE-INNER SETSCREW; SINGLE-INNER SETSCREW; SINGLE-INNER SETSCREW; SINGLE-INNER SETSCREW; UNKNOWN SCREWS; UNKNOWN SCREWS
Patient Outcome(s) Required Intervention;
-
-