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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH UNK - BIOMATERIAL - CEMENT; ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION

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SYNTHES GMBH UNK - BIOMATERIAL - CEMENT; ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION Back to Search Results
Catalog Number UNK - BIOMATERIAL - CEMENT: SP
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/05/2024
Event Type  malfunction  
Event Description
Device report from synthes reports an event in japan as follows: it was reported that this was a percutaneous pedicle screw fixation performed on (b)(6) 2023.In the surgery, the cement injection was stopped because a cement leak was visible on the image.14 minutes had passed since cement mixing and there were no viscosity problems.The leakage was observed during the fourth and final injection.The surgery was completed successfully.Immediately after the operation, the patient had no problems.The surgeon confirmed that it was a leak into the vertebral vein.No further information is available.This report is for one (1) unk - biomaterial - cement this is report 1 of 1 for complaint (b)(4).
 
Manufacturer Narrative
Product complaint # (b)(4).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.D9: complainant part is not expected to be returned for manufacturer review/investigation.H3, h4, h6: 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
The procedure was completed successfully with no surgical delay.
 
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 information is obtained that was not available for this medwatch, a follow-up medwatch will be filed as appropriate.
 
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Brand Name
UNK - BIOMATERIAL - CEMENT
Type of Device
ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
Manufacturer Contact
kate karberg
1302 wright lane east
west chester, PA 19380
3035526892
MDR Report Key18570255
MDR Text Key333557738
Report Number8030965-2024-01271
Device Sequence Number1
Product Code MNH
Combination Product (y/n)N
Reporter Country CodeJA
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
Report Date 01/22/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/24/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNK - BIOMATERIAL - CEMENT: SP
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/13/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
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