MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER SYSTEM POLYAXIAL WIDE LAG SCREW 5.5 8 X 80MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number	179704880
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/01/2021
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.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 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 system polyaxial wide lag screw 5.5 8 x 80mm.This is report 3 of 3 for (b)(4).

• Brand Name: VIPER SYSTEM POLYAXIAL WIDE LAG SCREW 5.5 8 X 80MM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 12490529
• Report Number: 1526439-2021-02039
• Device Sequence Number: 11610911
• Product Code: NKB
• UDI-Device Identifier: 10705034265728
• UDI-Public: 10705034265728
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K111571
• 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
• Report Date (Section B): 09/05/2021

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: 179704880
• Device Catalogue Number: 179704880
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/05/2021
• Initial 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