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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SàRL CH EXPEDIUM SPINE SYSTEM ROD 5.5 X 480MM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

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MEDOS INTERNATIONAL SàRL CH EXPEDIUM SPINE SYSTEM ROD 5.5 X 480MM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE Back to Search Results
Model Number 179762480
Device Problems Break (1069); Migration (4003)
Patient Problems Failure of Implant (1924); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 08/01/2022
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 procodes: osh, mnh, kwp, mni, kwq. Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received. 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 cyprus reports an event as follows: it was reported that on (b)(6) 2022, a revision surgery was performed on a patient that had underwent lumbar spine fusion (using 8 pedicle screws) 6 months ago. One month ago, the patient had an accident and slipped and fell to the floor. After that, the patient was in terrible pain and had an x-ray and a ct scan. The pain did not go away so the doctor decided to operate on the patient again. During the revision procedure, the surgeon could see that the screws of the crosslink plate were almost unlocked and one pedicle screw was falling out, creating a black color in the field around it. When the surgeon removed the crosslink plate, the rod was cut out as well. After the rod removal, it was noticed that a screw was falling out. The surgeon used the screwdriver to unscrew it and the screw came out cut as well. The screw could not be replaced because the thread shaft of the screw was bothering to insert another screw. Finally, the surgeon decided to add two more screws at the sacrum (bigger diameter), change one screw using a bigger diameter, and to replace two rods. This report is for a expedium spine system rod 5. 5 x 480mm. This is report 1 of 2 for (b)(4).
 
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Brand NameEXPEDIUM SPINE SYSTEM ROD 5.5 X 480MM
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 Key15311863
MDR Text Key298800366
Report Number1526439-2022-01487
Device Sequence Number1
Product Code NKB
UDI-Device Identifier10705034077437
UDI-Public(01)10705034077437
Combination Product (y/n)N
Reporter Country CodeCY
PMA/PMN Number
K111136
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/29/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/29/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number179762480
Device Catalogue Number179762480
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/20/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 08/29/2022 Patient Sequence Number: 1
Treatment
SI POLYAXL SCREW 5 X 50MM.; UNKNOWN PLATES.; UNKNOWN SCREWDRIVERS.
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