MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 5.5 EXP VERSE FEN SCR 5.0X40; ORTHOSIS, SPINAL PEDICLE FIXATION

Model Number 199723540

Device Problem Break (1069)

Patient Problems Foreign Body In Patient (2687); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/14/2021

Event Type  Injury  

Manufacturer Narrative

If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional device product codes: pml.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a synthes employee.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 (b)(6) as follows: it was reported that on (b)(6) 2021, the surgeon noticed in a post-surgery mri, that two expedium verse advanced screws were broken in the tip.The tip is located inside the vertebral body.On (b)(6) 2021 a revision surgery was performed.One screw (but not the tip) was removed and another two screws were placed to restore the stability of the implant.The second screw remained implanted, and should not cause problem to the stability of the implant.This report involves one (1) expedium verse spine system fenestrated cortical fix polyaxial screw 5.5 5.0 x 40mm.This is report 1 of 2 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.H10 additional narrative: d10: date of concomitant therapy is (b)(6) 2021.H6: no valid lot number was provided or found in the photos, therefore no device history record (dhr) review was completed.The dhr review will be revisited if a valid lot number is provided or the physical device is received.Investigation summary: the complaint device was not received for investigation.A photo investigation was performed based on the received images.The images were reviewed and the complaint condition is confirmed.The expedium verse screw appears to be broken near the tip in the x-rays.A definitive assignable root cause could not be determined based on the provided information.No valid lot number was provided or found in the photos, therefore no dhr review was completed.The dhr review will be revisited if a valid lot number is provided or the physical device is received.As the device was not returned, an as-received condition could not be assessed and a dimensional inspection and document/specification review were not completed.During the investigation, no product design issues or discrepancies were observed (based on the image) that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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.H6 - health effect - clinical code, health effect - impact code.

• Brand Name: 5.5 EXP VERSE FEN SCR 5.0X40
• Type of Device: ORTHOSIS, SPINAL PEDICLE 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: kara ditty-bovard ; chemin-blanc 38; le locle 02400 ; SZ 02400 ; 6103142063
• MDR Report Key: 13229883
• MDR Text Key: 287819389
• Report Number: 1526439-2022-00074
• Device Sequence Number: 1
• Product Code: MNI
• UDI-Device Identifier: 10705034403267
• UDI-Public: (01)10705034403267
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K160879
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 199723540
• Device Catalogue Number: 199723540
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/14/2021
• Initial Date FDA Received: 01/11/2022
• Supplement Dates Manufacturer Received: 01/11/2022
• Supplement Dates FDA Received: 02/08/2022
• 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: 5.5 EXP VERSE FEN SCR 5.0X40
• Patient Outcome(s): Required Intervention
• Patient Age: 17 YR