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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH MIS CANNULATED X-TAB 6X45MM TI ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

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MEDOS INTERNATIONAL SÃ RL CH MIS CANNULATED X-TAB 6X45MM TI ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE Back to Search Results
Catalog Number 186760045S
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Pain (1994)
Event Type  Injury  
Event Description
Device report from synthes reports an event in germany as follows: it was reported on (b)(6) 2022, that one week post op the patient got fever, one additional week later the sutures came off. Patient went back to hospital. Diagnosed that she has experienced an inflammation and had to undergo surgery again to clean and rinse the wound from the previous surgical approach and get a drainage tube inserted. Implant was not removed and also not replaced. Patient had to stay in hospital for 17 days for antibiotic treatment. Today ((b)(6) 2022) patient has still increased skin temperature at the surgical area. This report is for one (1) mis cannulated x-tab 6x45mm ti. This is report 5 of 5 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. If the information is unknown, not available or does not apply, the section/field of the form is left blank. Additional product codes: osh, kwq, mni, mnh and kwp. Complainant part is not expected to be returned for manufacturer review/investigation. Occupation: reporter is a j&j employee. 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 NameMIS CANNULATED X-TAB 6X45MM TI
Type of DeviceORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
Manufacturer (Section D)
MEDOS INTERNATIONAL SÃ RL CH
Manufacturer Contact
kate karberg
chemin-blanc 38
le locle 
SZ  
3035526892
MDR Report Key15310972
MDR Text Key298785083
Report Number1526439-2022-01482
Device Sequence Number1
Product Code NKB
UDI-Device Identifier10705034411651
UDI-Public(01)10705034411651
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K160904
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
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 Catalogue Number186760045S
Device Lot Number306839
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/24/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/30/2021
Is the Device Single Use? Yes
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 08/29/2022 Patient Sequence Number: 1
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