MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH EXPEDIUM SPINE SYSTEM UNIPLANAR SCREW 5.5 X 6.0 X 40MM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Catalog Number	179788640
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	12/18/2023
Type of Reportable Event	Serious Injury
Event or Problem 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 an expedium spine system uniplanar screw 5.5 x 6.0 x 40mm.This is report 8 of 10 for (b)(4).
Additional 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.D2: additional procodes: nkb, mni, osh, mnh.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.

• Brand Name: EXPEDIUM SPINE SYSTEM UNIPLANAR SCREW 5.5 X 6.0 X 40MM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• 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: 18484960
• Report Number: 1526439-2024-00578
• Device Sequence Number: 18411601
• Product Code: KWP
• UDI-Device Identifier: 10705034081397
• UDI-Public: (01)10705034081397
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K160904
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 179788640
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/17/2023
• Initial Report FDA Received Date: 01/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 5.5 TI CORT FIX 5X25MM; 5.5 TI CORT FIX 5X25MM; EXP TI UNI SCREW 6MM X 35MM; EXP TI UNI SCREW 6MM X 40MM; EXP TI UNI SCW 5MMX30MM; EXP TI UNI SCW 5MMX35MM; EXP TI UNI SCW 5MMX35MM; EXP TI UNI SCW 5MMX35MM; EXP TI UNI SCW 5MMX35MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown