MAUDE Adverse Event Report: DEPUY SPINE INC VIPER PRIME CFX XTAB 7X45MM TI; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number	186770345S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Stenosis (2263)
Date of Event	06/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional product code: kwp, kwq.Complainant part is expected to be returned for manufacturer review/ investigation but has yet to be received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.The product was not returned.Based on the information available, it has been determined that no corrective and 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 or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2021 the patient underwent for a revision procedure for treating lcs (lumbar canal stenosis).During the procedure, when surgeon used a screwhead adjuster, the screwhead of the viper prime came off.Previously, on (b)(6) 2019 a primary procedure (pps; percutaneous pedicle screw fixation) was performed at th12-l4.The revision procedure was completed with a replacement without delay.No further information is available.This complaint involves two (2) devices.This report is for (1) viper prime cfx xtab 7x45mm ti.This report is 1 of 1 for (b)(4).

• Brand Name: VIPER PRIME CFX XTAB 7X45MM TI
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 12077007
• Report Number: 1526439-2021-01316
• Device Sequence Number: 3565386
• Product Code: NKB
• UDI-Device Identifier: 10705034530185
• UDI-Public: 10705034530185
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K173095
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/03/2021

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
• Operator of Device: Health Professional
• Device Model Number: 186770345S
• Device Catalogue Number: 186770345S
• Device Lot Number: TBY|EY
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/03/2021
• Initial Report FDA Received Date: 06/28/2021
• Patient Sequence Number: 1