MAUDE Adverse Event Report: DEPUY SPINE INC MIS CANNULATED X-TAB 7X45MM TI; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	186770045
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional device product codes: kwp;nkb;mnh;mni;osh.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).Reporter is a j&j sales representative.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 or Problem Description
Device report from synthes reports an event in (b)(6) as follows: it was reported that a patient had a primary plif (l3/4/5) performed on (b)(6) 2015.On an unknown date it was found that the patient had suffered from adjacent degenerative scoliosis.On (b)(6) 2021 the patient is scheduled to undergo a revision procedure (interbody fusion at l2/3).No further information is available.This report is for one (1) viper system cannulated extended tab poly screw 5.5 x 7.0 x 45mm.This is report 4 of 6 for complaint (b)(4).

• Brand Name: MIS CANNULATED X-TAB 7X45MM TI
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 12600467
• Report Number: 1526439-2021-02128
• Device Sequence Number: 11771837
• Product Code: KWQ
• UDI-Device Identifier: 10705034129679
• UDI-Public: (01)10705034129679
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K160904
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/13/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: 186770045
• Device Catalogue Number: 186770045
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/13/2021
• Initial Report FDA Received Date: 10/08/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MIS CANNULATED X-TAB 7X45MM TI; MIS CANNULATED X-TAB 7X45MM TI; MIS CANNULATED X-TAB 7X45MM TI; MIS CANNULATED X-TAB 7X45MM TI; MIS CANNULATED X-TAB 7X45MM TI
• Outcome Attributed to Adverse Event: Required Intervention