MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER SYSTEM CORTICAL FIX POLYAXIAL SCREW 5.5 5 X 30MM; ORTHOSIS, SPONDYLOLISTHESIS SPINAL FIXATION

Catalog Number 186731530

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 12/18/2023

Event Type  Injury  

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: d2: additional procodes: kwq, nkb, kwp, mni.D9: complainant part is not expected to be returned for manufacturer review/investigation.D10: date of concomitant therapy is (b)(6) 2022.E3: initial reporter is a synthes employee.H3, h4, h6: 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 japan reports an event as follows: it was reported that on (b)(6) 2022, an unknown surgery was performed for adolescent idiopathic scoliosis.After the surgery on (b)(6) 2023, an infection was confirmed on the concave side.A revision procedure was scheduled for and performed on (b)(6) 2023.The set screws on t2, 3, 4, and 5 on the left were removed.The rod where the set screws were removed were cut and removed.Four uniplanar screws were removed on the left of t2-t5.The affected area was washed, and a hook was placed on t2.A side-side connector was installed at the upper end of t5, and titanium rod connection was performed between t2 and t5.The wound was closed.No further information is available.This report is for a viper system cortical fix polyaxial screw 5.5 5 x 30mm.This is report 1 of 4 for (b)(4).

• Brand Name: VIPER SYSTEM CORTICAL FIX POLYAXIAL SCREW 5.5 5 X 30MM
• Type of Device: ORTHOSIS, SPONDYLOLISTHESIS SPINAL FIXATION
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS INT SPINE; chemin blanc 38; le locle ; SZ
• Manufacturer Contact: kate karberg ; chemin-blanc 38; le locle ; SZ ; 3035526892
• MDR Report Key: 18494341
• MDR Text Key: 332678419
• Report Number: 1526439-2024-00582
• Device Sequence Number: 1
• Product Code: MNH
• UDI-Device Identifier: 10705034351605
• UDI-Public: (01)10705034351605
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K160904
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 186731530
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/17/2023
• 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: COCR PRCTRD ROD M 5.5MM.; COCR PRCTRD ROD M 5.5MM.; SFX,5.5,TI, LAT, SIZE A3.
• Patient Outcome(s): Required Intervention