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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY SPINE INC ROD, 300 MM; ORTHOSIS, SPINAL PEDICLE FIXATION
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DEPUY SPINE INC ROD, 300 MM; ORTHOSIS, SPINAL PEDICLE FIXATION Back to Search Results
Catalog Number 179762300X02
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Date 10/26/2023
Event Type  Injury  
Event Description
Device report from synthes reports an event in australia as follows: it was reported that the patient underwent revision (removal of hardware) october 26, 2023 due to infection and 3 broken screws insitu.Hardware sent to pathology for testing.Surgeon not concerned regarding broken hardware, submitting customer complaint as per protocol.This report is for one (1)rod, 300 mm.This is report 7 of 7 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.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.
 
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.If information is obtained that was not available for this medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
The revision procedure was completed successfully.Broken fragments were retained within the patient.
 
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Brand Name
ROD, 300 MM
Type of Device
ORTHOSIS, SPINAL PEDICLE FIXATION
Manufacturer (Section D)
DEPUY SPINE INC
325 paramount drive
raynham MA 02767
Manufacturer Contact
kate karberg
325 paramount drive
raynham, MA 02767
3035526892
MDR Report Key18190857
MDR Text Key328785152
Report Number1526439-2023-02416
Device Sequence Number1
Product Code MNI
UDI-Device Identifier10705034270067
UDI-Public(01)10705034270067
Combination Product (y/n)N
Reporter Country CodeAS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/22/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number179762300X02
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/06/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
5.5 EXP VERSE FEN SCR 7.0X45.; 5.5 EXP VERSE FEN SCR 7.0X45.; 5.5 EXP VERSE FEN SCR 7.0X45.; 5.5 EXP VERSE FEN SCR 7.0X45..; 5.5 EXP VERSE SCREW 7.0 X 45.; 5.5 EXP VERSE SCREW 7.0 X 45.
Patient Outcome(s) Required Intervention;
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