MAUDE Adverse Event Report: DEPUY SPINE INC EXPEDIUM VERSE SPINE SYSTEM VERSE CORRECTION KEY 5.5; ORTHOSIS, SPINAL PEDICLE FIXATION

Model Number 199721000

Device Problems Break (1069); Device-Device Incompatibility (2919)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/08/2022

Event Type  Injury  

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.Additional device product codes: mnh, osh, kwq, nkb, kwp.Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter facility address: (b)(6).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 austria as follows: it was reported that on november 8, 2022, the thread of a verse pedicle screw was destroyed and therefore no locking cap could be placed.The screw had to be left open in an idiopathic scoliosis case.There was a delay of 5 minutes due to the event.The procedure was completed successfully.Fragments were generated, but they were easily removed without additional intervention.No further information is available.This report involves one expedium verse spine system verse correction key 5.5.This is report 3 of 3 for (b)(4).

• Brand Name: EXPEDIUM VERSE SPINE SYSTEM VERSE CORRECTION KEY 5.5
• 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 Key: 15895336
• MDR Text Key: 304620479
• Report Number: 1526439-2022-02051
• Device Sequence Number: 1
• Product Code: MNI
• UDI-Device Identifier: 10705034466132
• UDI-Public: 10705034466132
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K142185
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial

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 Number: 199721000
• Device Catalogue Number: 199721000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/08/2022
• Initial Date FDA Received: 12/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK - SCREWS: EXPEDIUM VERSE; VERSE CORRECTION KEY
• Patient Outcome(s): Required Intervention
• Patient Age: 13 YR
• Patient Sex: Female