MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH 5.5 EXP VERSE FEN SCR 6.0X40; ORTHOSIS, SPINAL PEDICLE FIXATION

Model Number 199723640

Device Problem Break (1069)

Patient Problem Non-union Bone Fracture (2369)

Event Date 11/09/2022

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.Procode: additional product code: pml.Device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.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 australia as follows: it was reported that patient was requiring a l4/5 spinal fusion revision from the primary surgery performed in 2000.The left l5 screw shaft had broken insitu.The patient had not successfully fused, the surgeon considered many other contributing factors, yet noted that the instrumentation was not the issue and did not factor into the success of this case.Patient status/ outcome / consequences :yes patient consequence description/was there a clinical outcome experienced by the patient (infection, inflammation, etc.)? broken screw requiring revision.This report is for one (1) 5.5 exp verse fen scr 6.0x40 this is report 1 of 1 for complaint (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: h3, h4, h6: the photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned photo.Visual analysis found that the photo was a single ct scan image and showed a polyaxial pedicle screw broken in the shaft below the head where it transitions to the threaded portion of the shaft.The construct shown is a one level rod and screw fixation and showed that the area between the vertebrae had not fused.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.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the broken screw is visible in the returned image.There is no indication that a design or manufacturing issue has caused the complaint condition and the root cause is most likely due to the failure to fuse between the vertebrae.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.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.E1: updated initial reporter.E3: reporter is a j&j employee.

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: d6a.E1: initial reporter facility name and address.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.E1: corrected initial reporter e2: initial reporter is health care professional.

• Brand Name: 5.5 EXP VERSE FEN SCR 6.0X40
• 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: kate karberg ; chemin-blanc 38; le locle 02400 ; SZ 02400 ; 3035526892
• MDR Report Key: 15923333
• MDR Text Key: 304873380
• Report Number: 1526439-2022-02074
• Device Sequence Number: 1
• Product Code: MNI
• UDI-Device Identifier: 10705034403090
• UDI-Public: (01)10705034403090
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K160879
• 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,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: 199723640
• Device Catalogue Number: 199723640
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/09/2022
• Initial Date FDA Received: 12/06/2022
• Supplement Dates Manufacturer Received: 12/28/2022; 01/19/2023
• Supplement Dates FDA Received: 01/12/2023; 01/23/2023
• 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