• 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 EXPEDIUM VERSE SPINE SYSTEM POLYAXIAL SCREW 5.5 5.0 X 30MM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

  • 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 EXPEDIUM VERSE SPINE SYSTEM POLYAXIAL SCREW 5.5 5.0 X 30MM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD Back to Search Results
Model Number 199721001
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Date 01/01/2022
Event Type  Injury  
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. If the information is unknown, not available or does not apply, the section/field of the form is left blank. Additional product codes: osh, mnh, kwp, mni, kwq. Complainant part is not expected to be returned for manufacturer review/investigation. 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 italy as follows: it was reported the patient experienced a post-operative infection. This is report 11 of 12 for (b)(4). Additional impacted products are captured on related complaint (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameEXPEDIUM VERSE SPINE SYSTEM POLYAXIAL SCREW 5.5 5.0 X 30MM
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 INT SPINE
chemin blanc 38
le locle
SZ
Manufacturer Contact
kate karberg
325 paramount drive
raynham, MA 02767
3035526892
MDR Report Key15045953
MDR Text Key296100373
Report Number1526439-2022-01238
Device Sequence Number1
Product Code NKB
UDI-Device Identifier10705034442471
UDI-Public10705034442471
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K142185
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 Received07/18/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number199721001
Device Catalogue Number199721530
Device Lot Number256334
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/26/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/20/2019
Is the Device Single Use? Yes
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 07/18/2022 Patient Sequence Number: 1
Treatment
5.5 EXP VERSE SCREW 5.0 X 30; 5.5 EXP VERSE SCREW 5.0 X 30; 5.5 EXP VERSE SCREW 5.0 X 30; 5.5 EXP VERSE SCREW 5.0 X 30; 5.5 EXP VERSE SCREW 5.0 X 30; 5.5 EXP VERSE SCREW 5.0 X 30; 5.5 EXP VERSE SCREW 5.0 X 30; 5.5 EXP VERSE SCREW 5.0 X 30; 5.5 EXP VERSE SCREW 5.0 X 30; 5.5 EXP VERSE SCREW 5.0 X 30; 5.5 EXP VERSE SCREW 5.0 X 30; 5.5 EXP VERSE SCREW 5.0 X 30; 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; 5.5 EXP VERSE UNITIZED SET SCR; ROD, 480 MM; ROD, 480 MM; ROD, 480 MM; ROD, 480 MM; ROD, 480 MM; ROD, 480 MM
-
-