MAUDE Adverse Event Report: DEPUY SPINE INC VIPER2 LORDOTIC ROD-85MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number	186788085
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional narrative: additional product codes: mnh, kwp, mni, kwq, and 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 or Problem Description
Device report from synthes (b)(6) reports an event as follows: it was reported that on (b)(6) 2021 the primary posterior fusion was performed.On (b)(6) 2021 it was found that the rod had broken off.The patient was scheduled to undergo a revision procedure on (b)(6) 2021; it is unknown if the procedure occurred as planned.This report is for a viper rod.This is report 1 of 1 for (b)(4).
Event or Problem Description
Device report from synthes japan reports an event as follows: it was reported that on (b)(6) 2021 the primary posterior fusion was performed.On (b)(6) 2021 it was found that the rod had broken off and the screw had loosened.A revision procedure was performed on (b)(6) 2021.The broken titanium rod was replaced with a cobalt rod.Concomitant devices: unknown locking/set screw (part# unknown, lot# unknown, qty unknown).Conn o/o sd top ntch 5.5x5.5 t (part# 179771555, lot# unknown, qty two).This report is for a viper rod.This is report 1 of 3 for (b)(4).
Additional 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.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.

• Brand Name: VIPER2 LORDOTIC ROD-85MM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 12342002
• Report Number: 1526439-2021-01726
• Device Sequence Number: 19967376
• Product Code: NKB
• UDI-Device Identifier: 10705034131825
• UDI-Public: (01)10705034131825
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K111136
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2021

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
• Operator of Device: Health Professional
• Device Model Number: 186788085
• Device Catalogue Number: 186788085
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/21/2021
• Supplement Date Received by Manufacturer: 09/05/2021
• Initial Report FDA Received Date: 08/19/2021
• Supplement Report FDA Received Date: 09/17/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CONN O/O SD TOP NTCH 5.5X5.5 T; UNKNOWN LOCKING/SET SCREWS; VIPER TI SAI POLY 8X80MM; VIPER TI SAI POLY 8X80MM; VIPER2 LORDOTIC ROD-85MM
• Outcome Attributed to Adverse Event: Required Intervention