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

Device Problem Device Slipped (1584)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/01/2021

Event Type  Injury  

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 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
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): SENTIO (INNOVATIVE SURGICAL SOLUTIONS, LLC); 50461 west pontiac trail; wixom MI 48393
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 12490529
• MDR Text Key: 271990940
• Report Number: 1526439-2021-02039
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034265728
• UDI-Public: 10705034265728
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K111571
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 179704880
• Device Catalogue Number: 179704880
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/05/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 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
• Patient Outcome(s): Required Intervention