MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNK - CONSTRUCTS: EXPEDIUM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

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

Patient Problems Hematoma (1884); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Non-union Bone Fracture (2369); Spinal Cord Injury (2432); Post Operative Wound Infection (2446); Thrombosis/Thrombus (4440); Unspecified Tissue Injury (4559); Insufficient Information (4580)

Event Type  Injury  

Event Description

This report is being filed after the review of a clinical evaluation report (cer) from a database related research activity (drra) for a total of 230 patients (mean age of 49 years) who were operated with the combination of expedium posterior instrumentation and opal interbody cage between january 02, 2006, and november 22, 2020.The following complications have been identified as per the (b)(6) spine registry ((b)(6)) report: general complications - intraoperative complications: ¿ 6 patients had dural tear.¿ 1 patient had misplaced implant.General complications ¿ postoperative complications within 1st follow-up year: ¿ 2 patients had deep surgical site infection.¿ 4 patients had superficial surgical site infection.General complications ¿ reintervention during stay: ¿ 1 patient drain of deep infection.¿ 1 patient had repair of dural injury.¿ 1 patient had replacement of implant.Readmission: ¿ 1 patient had adjustment of implant.¿ 5 patients had drain of deep infection.¿ 1 patient had drain of hematoma.¿ 3 patients had refusion.¿ 5 patients had removal of implant.¿ 1 patient had repair of dural injury.¿ 1 patient had readmission to stop bleeding.This is for depuy spine expedium posterior instrumentation.This is report 1 of 3 for (b)(4).

Manufacturer Narrative

There are multiple patients.All known information is provided in the literature article.This report is for an unknown expedium construct/unknown lot.Part and lot number are unknown; udi number is unknown.There are multiple unknown dates of implantation between january 02, 2006 and november 22 2020.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

This report is being filed after the review of a clinical evaluation report (cer) from a database related research activity (drra) for a total of 357 patients (mean age of 48 years, 53 percent are females) who were operated with the combination of expedium posterior instrumentation and opal interbody cage between january 02, 2006 and september 30, 2022.The following complications have been identified as per the swedish spine registry (swespine) report: general complications ¿ postoperative complications within 1st follow-up year: 12 patients had infection, 1 patient had thrombosis.Reoperations 1: 3 patients had adjustment of implant.1 patient had drain of hematoma.6 patients had drain of deep infection.1 patient had redecompression.5 patients had refusion.8 patients had removal of implant.2 patients had repair of dural injury.1 patient had reoperation to stop bleeding.5 patients had other unknown reoperations.Reoperation 2: 1 patient had drain of deep infection.1 patient had removal of implant.1 patient had other unknown reoperation.

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.H10 additional narrative: b5: event description updated after receipt of new information.D3: manufacturer contact updated.H6: health effect clinical codes added.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

This report is being filed after the review of a clinical evaluation report (cer) from a database related research activity (drra) for a total of 422 patients (mean age of 47 years) who were operated with the combination of expedium posterior instrumentation and opal interbody cage between between 2010 and december 31, 2023.The following complications have been identified as per the swedish spine registry (swespine) report: general complications - intraoperative complications: 7 patients had dural tear.2 patients had misplaced implant.1 patient had other intraoperative complication.General complications ¿ postoperative complications within 1st follow-up year: 14 patients had infection.1 patient had thrombosis.Reasons for reoperation 1: 4 patient had adjustment of implant.1 patient had drain of hematoma.6 patients had drain of infection.1 patient had redecompression.6 patients had refusion.11 patients had removal of implant.2 patient had repair of dural injury.1 patient had reoperation to stop bleeding.1 patient had reoperation due to other reasons.Reasons for reoperation 2: 2 patients had drain of infection.3 patients had removal of implant.1 patient had reoperation due to other reasons.This is for depuy spine expedium posterior instrumentation.

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: UNK - CONSTRUCTS: EXPEDIUM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: kara ditty-bovard ; chemin-blanc 38; le locle ; SZ ; 6103142063
• MDR Report Key: 12633183
• MDR Text Key: 281671647
• Report Number: 1526439-2021-02168
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2024
• 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
• Patient Outcome(s): Required Intervention