MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER 2 SYSTEM ROD, STRAIGHT 480MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	186789480
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.(b)(4).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 australia reports an event as follows: it was reported that on an unknown date the construct broke when the patient bent over.The left rod fractured at the l5/s1 level.Upon further investigation intra operatively, it was found that the 10mm cfx screw at the level of s1 had broken.Both the broken piece of the rod from l5 to s1 and the broken s1 screw were removed.The s1 broken 10mm screw that was removed, wasn¿t replaced as it was the maximum diameter pedicle screw available ( no bigger diameter pedicle screw than 10mm).Another rod was connected to the existing iliac screw and reconnected to the proximal construct with a connector.Procedure was successfully completed.Patient status is unknown.This report is for one (1) viper 2 system rod, straight 480mm.This is report 2 of 2 for (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).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.H10 additional narrative: h3, h6: the investigation could not be completed, no conclusion could be drawn at the time of filing this report.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
Additional event information: the set screw was actually part of the failed construct.This complaint involves three (3) devices.

• Brand Name: VIPER 2 SYSTEM ROD, STRAIGHT 480MM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 11357435
• Report Number: 1526439-2021-00327
• Device Sequence Number: 3979992
• Product Code: KWQ
• UDI-Device Identifier: 10705034133522
• UDI-Public: 10705034133522
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K071860
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• 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,Followup
• Report Date (Section B): 01/31/2021

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: 186789480
• Device Catalogue Number: 186789480
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/31/2021
• Supplement Date Received by Manufacturer: 04/09/2021
• Initial Report FDA Received Date: 02/22/2021
• Supplement Report FDA Received Date: 04/13/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention