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

MAUDE Adverse Event Report: DEPUY SPINE INC SYMPHONY OCT SYSTEM POLYAXIAL SCREW DRIVER RETENTION SLEEVE; CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY

  • 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 SPINE INC SYMPHONY OCT SYSTEM POLYAXIAL SCREW DRIVER RETENTION SLEEVE; CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY Back to Search Results
Model Number 2020-00-401
Device Problem Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
Device report from canada reports an event as follows: it was reported that on an unknown date, the screwdriver sleeve in question was found to be bent, and the screwdriver shaft wouldn¿t allow for it to slide up and down easily.There was no reported adverse patient outcome.No further information is available.This report is for a symphony oct system polyaxial screw driver retention sleeve.This is report 2 of 2 for (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.Common device name: additional procode: olo.Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter is a synthes employee.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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SYMPHONY OCT SYSTEM POLYAXIAL SCREW DRIVER RETENTION SLEEVE
Type of Device
CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY
Manufacturer (Section D)
DEPUY SPINE INC
325 paramount drive
raynham MA 02767
Manufacturer Contact
kate karberg
chemin-blanc 38
le locle 
SZ  
3035526892
MDR Report Key15240665
MDR Text Key305176290
Report Number1526439-2022-01412
Device Sequence Number1
Product Code GEA
UDI-Device Identifier10705034532776
UDI-Public(01)10705034532776
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K191943
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
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 Model Number2020-00-401
Device Catalogue Number202000401
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/20/2022
Initial Date FDA Received08/17/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
POLY SCREW DRIVER SHFT X20
-
-