MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: USS; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

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

Patient Problems Failure of Implant (1924); Non-union Bone Fracture (2369); Post Operative Wound Infection (2446)

Event Date 10/16/2021

Event Type  Injury  

Event Description

This report is being filed after the review of the following journal article: wenning k, et al (2021), comparison of lumbopelvic fixation and iliosacral screw fixation for the treatment of bilateral sacral fractures, j orthop surg res, volume 16, pages 1-8, (germany).The purpose of this study was to evaluate the differences between iliosacral screw fixation (isf) and lumbopelvic fixation (lpf) in bilateral sacral fractures regarding intraoperative procedures, complications and postoperative mobilization.The secondary aim was to determine whether demographics influence surgical treatment.Between january 2016 and december 2019, 77 patients treated for unstable bilateral sacral fractures were included in the study.Lumbopelvic fixation was performed in 29 patients (12 males, 17 females, mean age 62.2+/-17.7 years) and they were implanted with the unknown synthes universal spine system (uss) lumbopelvic implants.Iliosacral screw fixation in combination with unilateral or bilateral screwing of the upper pubic ramus was performed in 48 patients (8 males, 40 females, mean age 75.9 +/-14.0 years) and they were implanted with the unknown synthes 7.3 mm iliosacral screws.Patients were evaluated at regular and consistent intervals of 2 weeks, 6 weeks, 12 weeks, 6 months and 1 year if possible.Complications were reported as follows: (lumbopelvic fixation group) 4 patients had deep wound infection.Patients underwent local debridement and intravenous followed by oral antibiotic administration.1 patient had nonunion with consecutive hardware failure.The patient underwent surgical revision consisting of rod replacement and autologous bone grafting.2 patients had hardware removal.(iliosacral screw fixation group) 1 patient had hematoma.The patient underwent local debridement and intravenous followed by oral antibiotic administration.5 patients had screw malpositioning revealed by postoperative computed tomography and had consecutive hardware change.1 patient had hardware failure and underwent hardware change.5 patients had hardware removal.This report is for an unknown uss construct.This is report 1 of 1 for (b)(4).A copy of the clinical evaluation form is being submitted with this regulatory report.

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.Between january 2016 and december 2019, 77 patients treated for unstable bilateral sacral fractures were included in the study.Lumbopelvic fixation was performed in 29 patients (12 males, 17 females, mean age 62.2+/-17.7 years) and they were implanted with the unknown synthes universal spine system lumbopelvic implants.Iliosacral screw fixation in combination with unilateral or bilateral screwing of the upper pubic ramus was performed in 48 patients (8 males, 40 females, mean age 75.9 +/-14.0 years) and they were implanted with the unknown synthes 7.3 mm iliosacral screws.Patients were evaluated at regular and consistent intervals of 2 weeks, 6 weeks, 12 weeks, 6 months and 1 year if possible.Exact date of event is unknown; october 16, 2021 is the date the literature article was published.This report is for an unknown uss construct/unknown lot.Part and lot number are unknown; udi number is unknown.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.

• Brand Name: UNK - CONSTRUCTS: USS
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14976965
• MDR Text Key: 295614287
• Report Number: 8030965-2022-04691
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2022
• 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: 06/13/2022
• 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
• Patient Outcome(s): Required Intervention