MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH EXPEDIUM SPINE SYSTEM DUAL INNER SET SCREW 6.35; PEDICLE SCREW SPINAL SYSTEM, ADOLESCENT IDIOPATHIC SCOLIOSIS

Model Number 179922000

Device Problem Migration (4003)

Patient Problem Failure of Implant (1924)

Event Date 11/03/2022

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2022, the patient presented with an expedium 6.35 distal uniplanar screw with di set screw that slipped and dislodged from rod construct.The patient presented with no pain, but a revision surgery was performed to replace screw/rod construct.There was no surgical delay.No further information is available.This report involves one expedium spine system dual inner set screw 6.35.This is report 3 of 3 for (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional device product codes: mni, nkb, kwp, mnh, kwq.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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.H6: the product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the exp 635 ti di setscrew, p/n: 179922000, exhibits signs of normal use.No significant product problems were observed on the surface of the device.Migration of the device can not be confirmed as no patient radiographs were provided to assess the condition.A dimensional inspection was unable to be performed due to not being applicable to the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed as the exp 635 ti di setscrew, p/n: 179922000 was found to have no damage or defects.No definitive root cause could be determined.There was no indication that a design or manufacturing issue contributed to the complaint.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Drawing/specifications reviewed? yes, reviewed.Dimensional inspection: n/a.Device history lot- a manufacturing record evaluation was performed for the finished device.Product code: 179922000.Lot number: 333461.It was electronically reviewed and no non-conformances / manufacturing irregularities were identified during the manufacturing process.The product was released on: 13/01/2022.Qty: (b)(4).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 DUAL INNER SET SCREW 6.35
• Type of Device: PEDICLE SCREW SPINAL SYSTEM, ADOLESCENT IDIOPATHIC SCOLIOSIS
• 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 02400 ; SZ 02400 ; 3035526892
• MDR Report Key: 15904269
• MDR Text Key: 304684264
• Report Number: 1526439-2022-02054
• Device Sequence Number: 1
• Product Code: OSH
• UDI-Device Identifier: 10705034088907
• UDI-Public: 10705034088907
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160904
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 179922000
• Device Catalogue Number: 179922000
• Device Lot Number: 333461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/13/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: EXP 6.35 COCR ROD W/HEX ENDS 4; EXP 6.35 TI UNI 7 X 45MM
• Patient Outcome(s): Required Intervention
• Patient Age: 17 YR
• Patient Sex: Female