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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 6.0 X 45MM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

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MEDOS INTERNATIONAL SàRL CH EXPEDIUM VERSE SPINE SYSTEM POLYAXIAL SCREW 5.5 6.0 X 45MM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE Back to Search Results
Model Number 199721645
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/14/2022
Event Type  malfunction  
Event Description
Device report from china reports an event as follows: it was reported that during a procedure for lumbar spondylolisthesis on (b)(6) 2022, after the verse screw was implanted, the screw became locked and could not be rotated while the screw cap was not fixed. The surgeon removed the locked screws from the patient and replaced them with devices of other brands to complete the procedure, prolonging the surgery for approximately 3 hours. There is no patient outcome. This report is for a expedium verse spine system polyaxial screw 5. 5 6. 0 x 45mm. This is report 1 of 3 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. If the information is unknown, not available or does not apply, the section/field of the form is left blank. Additional procode: mni, kwq. Kwp, mnh, osh. Complainant part is expected to be returned for manufacturer review/ investigation, but has yet to be received. 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 6.0 X 45MM
Type of DeviceORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
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
chemin-blanc 38
le locle 02400
SZ   02400
3035526892
MDR Report Key15007822
MDR Text Key296234928
Report Number1526439-2022-01043
Device Sequence Number1
Product Code NKB
UDI-Device Identifier10705034442273
UDI-Public(01)10705034442273
Combination Product (y/n)N
Reporter Country CodeCH
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
Type of Report Initial,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/13/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number199721645
Device Catalogue Number199721645
Device Lot Number297428
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/15/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/19/2021
Is the Device Single Use? Yes
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 07/13/2022 Patient Sequence Number: 1
Treatment
5.5 EXP VERSE SCREW 6.0 X 45; 5.5 EXP VERSE SCREW 6.0 X 45
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