• 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 EXP TI POLY SCREW 7.5MMX30MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

  • 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 EXP TI POLY SCREW 7.5MMX30MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD Back to Search Results
Model Number 179712030
Device Problem Break (1069)
Patient Problem Unspecified Tissue Injury (4559)
Event Type  Injury  
Manufacturer Narrative
Additional procode: kwp; kwq; mnh; mni; osh.Complainant part is not expected to be returned for manufacturer review/investigation.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
Device report from synthes reports an event in (b)(6) as follows: it was allegedly reported by the patient's legal counsel that on (b)(6) 2017, a transpedicular screw that was used for spine stabilization has broken causing unspecified injuries which required medical intervention.There is no further information available.Concomitant device reported: unknown rod(part# unknown, lot# unknown, quantity# unknown).Unknown set screw(part# unknown, lot# unknown, quantity# unknown).This report is for one (1) exp ti poly screw 7.5mmx30mm.This is report 1 of 1 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.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
EXP TI POLY SCREW 7.5MMX30MM
Type of Device
ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
Manufacturer (Section D)
DEPUY SPINE INC
325 paramount drive
raynham MA 02767
MDR Report Key11619105
MDR Text Key243941502
Report Number1526439-2021-00623
Device Sequence Number1
Product Code NKB
UDI-Device Identifier10705034066561
UDI-Public10705034066561
Combination Product (y/n)N
PMA/PMN Number
K160904
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other
Type of Report Initial,Followup
Report Date 03/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number179712030
Device Catalogue Number179712030
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 03/09/2021
Initial Date FDA Received04/06/2021
Supplement Dates Manufacturer Received09/20/2021
Supplement Dates FDA Received09/29/2021
Patient Sequence Number1
Treatment
UNK - SCREW/ROD CONSTRUCT ACCESSORIES; UNKNOWN LOCKING/SET SCREWS; UNK - SCREW/ROD CONSTRUCT ACCESSORIES; UNKNOWN LOCKING/SET SCREWS
Patient Outcome(s) Required Intervention;
-
-