MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER2 STRAIGHT ROD300MM, COCR; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	196789300
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)
Date of Event	01/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Device report from (b)(6) reports an event as follows: it was reported that patient underwent revision of scoliosis fixation ranging from t3-l1 on (b)(6) 2022.The last 2 caudal screws, on both sides, found their respective setscrews loosened.Surgeon discovered unstable montage and metallosis.Four screws were replaced in total and the fixation was extended by one level caudally.This report is for an unknown viper screw.This is report 9 of 9 for (b)(4).
Additional Manufacturer Narrative
Date of event is an unknown date in 2022.This report is for an unknown rod/unknown lot.Part and lot number are unknown; udi number is unknown.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a synthes employee.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.
Additional Manufacturer Narrative
Date of event is an unknown date in 2022.This report is for an unknown rod/unknown lot.Part and lot number are unknown; udi number is unknown.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a synthes employee.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 (b)(6) reports an event as follows: it was reported that patient underwent revision of scoliosis fixation ranging from t3-l1 on (b)(6) 2022.The last 2 caudal screws, on both sides, found their respective setscrews loosened.Surgeon discovered unstable montage and metallosis.Four screws were replaced in total and the fixation was extended by one level caudally.This report is for an unknown viper screw.This is report 9 of 9 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.H10 additional narrative: b5; d6a.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
It was further reported that initially a patient underwent a t4 - l1 minimally invasive posterior approach arthrodesis procedure on (b)(6) 2018.A metallosis was discovered post-operatively around the last 4 caudal screws.
Additional Manufacturer Narrative
Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, 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.A photo investigation was completed: visual analysis of the provided photo revealed there is not sufficient evidence that could be attributed to the reported condition.No issues were identified.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.As part of depuy synthese quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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.
Additional Manufacturer Narrative
Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, 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.A product investigation was completed: visual analysis of the returned sample revealed that the rod was cut.The broken fragment was not returned.No dimensional inspection was performed due to post-manufacturing damage.Complaint relevant dimensions cannot be taken.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces as mentioned in the event description.The current manufacturing drawing was reviewed.As part of depuy synthese quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed as the observed condition of the rod would not contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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 STRAIGHT ROD300MM, COCR
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: kara ditty-bovard ; chemin-blanc 38; le locle ; SZ ; 6103142063
• MDR Report Key: 13584619
• Report Number: 1526439-2022-00274
• Device Sequence Number: 17235357
• Product Code: NKB
• UDI-Device Identifier: 10705034295251
• UDI-Public: (01)10705034295251
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K111136
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup

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: 196789300
• Device Catalogue Number: 196789300
• Device Lot Number: GM50065
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/24/2022
• Supplement Date Received by Manufacturer: 02/23/2022; 04/08/2022; 04/27/2022
• Initial Report FDA Received Date: 02/23/2022
• Supplement Report FDA Received Date: 03/24/2022; 04/12/2022; 05/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MIS CANN POLY SCW 6X40MM,TI; SINGLE-INNER SETSCREW; SINGLE-INNER SETSCREW; SINGLE-INNER SETSCREW; SINGLE-INNER SETSCREW; UNK - MONO/POLYAXIAL SCREWS: VIPER; UNK - MONO/POLYAXIAL SCREWS: VIPER; UNK - MONO/POLYAXIAL SCREWS: VIPER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown