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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

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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  
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 9 of 12 for (b)(4). Additional impacted products are captured on related complaint (b)(4).
 
Manufacturer Narrative
Additional narrative: 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.
 
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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 Key15045865
MDR Text Key296123094
Report Number1526439-2022-01236
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
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