• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 DXTEND SCREW NO LOCK D4.5X18MM; DELTA XTEND IMPLANTS : SCREWS

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

DEPUY FRANCE SAS - 3003895575 DXTEND SCREW NO LOCK D4.5X18MM; DELTA XTEND IMPLANTS : SCREWS Back to Search Results
Catalog Number 130770018
Device Problem Difficult to Remove (1528)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/28/2023
Event Type  malfunction  
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.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 depuy synthes japan reports an event as follows: it was reported that this was a rtsa for cta performed on (b)(6) 2023.The surgeon tried to insert the screw into the screw hole in front of metagren for fixation; however, it did not work.There was no surgical delay and no harm to the patient.No further information is available.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot: a manufacturing record evaluation (nc search) was performed for the finished device product 130770018, lot 5422801, and no non-conformances / manufacturing irregularities were identified.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
DXTEND SCREW NO LOCK D4.5X18MM
Type of Device
DELTA XTEND IMPLANTS : SCREWS
Manufacturer (Section D)
DEPUY FRANCE SAS - 3003895575
7 allee irene joliot-curie
b.p. 256
saint priest cedex 69801
FR  69801
Manufacturer (Section G)
JTE WARSAW MFG SITE
700 orthopaedic drive
warsaw IN
Manufacturer Contact
kate karberg
700 orthopaedic dr.
warsaw, IN 46581-0988
3035526892
MDR Report Key17514058
MDR Text Key321180502
Report Number1818910-2023-16623
Device Sequence Number1
Product Code HSD
UDI-Device Identifier10603295027782
UDI-Public10603295027782
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K192855
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/11/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number130770018
Device Lot Number5422801
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/08/2023
Initial Date FDA Received08/11/2023
Supplement Dates Manufacturer Received08/29/2023
Supplement Dates FDA Received08/29/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/08/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
-
-