MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH EXPEDIUM SPINE SYSTEM UNIPLANAR SCREW 5.5 X 5.0 X 30MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number 179788530

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

Patient Problem Unspecified Infection (1930)

Event Date 01/01/2023

Event Type  Injury  

Event Description

Device report from synthes reports an event in japan as follows: it was reported that an unknown surgery for adolescent idiopathic scoliosis was completed on (b)(6), 2022.After the surgery, on (b)(6), 2023, an infection was confirmed on concave side.Revision surgery occurred on (b)(6), 2023.During the revision, the set screws on t2·3·4·5 on the left were removed.The rod where the set screws were removed were cut by the t-saw.The rods were removed.Four of the uniplanar screws (5.0 diameter 30mm long) on the left t2-t5 were removed.The affected area was washed.The hook was placed on t2 (wide blade/throat 10).Side-side connector installed at the upper end of t5.Titanium rod connection was performed between t2 and t5.The wound was closed.This report is for one expedium spine system uniplanar screw 5.5 x 5.0 x 30mm for (b)(4).This complaint is linked to (b)(4).

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.B3: unknown when infection occurred.D9: complainant part is not expected to be returned for manufacturer review/investigation.D10 concomitant therapy date (b)(6), 2022.E1: initial reporter is j&j company representative.G4: device is not distributed in the united states, but is similar to device marketed in the usa.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.

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.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: EXPEDIUM SPINE SYSTEM UNIPLANAR SCREW 5.5 X 5.0 X 30MM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• 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 ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 18504567
• MDR Text Key: 332794250
• Report Number: 1526439-2024-00630
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 10705034081205
• UDI-Public: (01)10705034081205
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 179788530
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2024
• 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: EXP TI UNI SCW 5MMX30MM.; EXP TI UNI SCW 5MMX30MM.; EXP TI UNI SCW 5MMX30MM.; EXP TI UNI SCW 5MMX30MM.; EXP TI UNI SCW 5MMX30MM.; EXP TI UNI SCW 5MMX30MM.; EXP TI UNI SCW 5MMX30MM.; EXP TI UNI SCW 5MMX30MM.; SI POLYAXL EXT TAB 6 X 40MM.; SI POLYAXL EXT TAB 6 X 45MM.
• Patient Outcome(s): Required Intervention