MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNK - MONO/POLYAXIAL SCREWS: EXPEDIUM VERSE; ORTHOSIS, PEDICLE SPINAL FIXATION

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

Patient Problem Spinal Cord Injury (2432)

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: d1, d2a, d2b, d3, d4, g4 ¿ 510k: this report is for an unknown mono/polyaxial screws: expedium verse/unknown lot.Part and lot numbers are unknown; udi number is unknown.D9: complainant part is not expected to be returned for manufacturer review/investigation.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 synthes reports an event in japan as follows: this report is being filed after the review of the following journal article: miyazaki, m.Et al.(2023), analysis of accuracy of pedicle screw placement in dysplastic pedicles in adolescent idiopathic scoliosis using the pedicle expansion technique with ct-based navigation, journal of orthopaedic science, vol.Xx, pages 1-8 (japan).This study aimed to study the accuracy of pedicle screw (ps) insertion into dysplastic pedicles in adolescent idiopathic scoliosis (ais) comparing cannulated screw using the pedicle expansion technique (pet) versus conventional technique.From august 2011 to september 2020, 42 patients with ais underwent posterior spinal correction and fusion with pedicle screw instrumentation.The patients were divided into 2 groups; pet group (1 male and 20 females) and the conventional group (3 males and 18 females).Pet group used a cannulated ps (expedium verse, depuy synthes, raynham, ma) with a diameter of 4.35 mm while the conventional group used uss ii (depuy synthes, raynham, ma) or cd horizon solera (medtronics, memphis, tn).The following complications were reported as follows: pet group (n=6) perforation.Conventional group (n=17) perforation (n=2) pedicle screws were removed during a second operation and not replaced due to a medial perforation (grade 3) at the right l1 level and lateral perforation (grade 3) at the right t6 level.This report is for an unknown synthes uss ii and an expedium verse.This report involves one unk - mono/polyaxial screws: expedium verse.This is report 1 of 1 for (b)(4).This report is related to (b)(4).

• Brand Name: UNK - MONO/POLYAXIAL SCREWS: EXPEDIUM VERSE
• Type of Device: ORTHOSIS, PEDICLE SPINAL FIXATION
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: kate karberg ; chemin-blanc 38; le locle ; SZ ; 3035526892
• MDR Report Key: 17260236
• MDR Text Key: 318444972
• Report Number: 1526439-2023-01214
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/12/2023
• 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
• Patient Outcome(s): Required Intervention