MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: USS II; ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION

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

Patient Problems Pulmonary Embolism (1498); Hemorrhage/Bleeding (1888)

Event Type  Injury  

Event Description

This report is being filed after the review of the following journal article: linhart, c.Et al (2022), jumper¿s fracture of the sacrum: a novel and reproducible way for successful reduction and fixation, european spine journal, vol.31 (xx), pages 18¿27 (germany).The aim of this observational retrospective study to describe a technique where reduction is possible through combination of restoring length via rod distraction and lordosis by using a hinge mechanism between the longitudinal rods and a horizontal rod between both posterior superior iliac processes.Between january 2015 and december 2019, a total of 24 patients (17 male and 7 female) with an average age 47 ± 16.3 years who underwent iliolumbar stabilization of a jumper's fracture of the sacrum were included.The technique is based on one of the most frequently used implants for the spine, the universal spine system (ussii) from depuy synthes, which makes it highly reproducible for interested surgeons.Thus, reduction is performed via its specific surgical instruments, namely the distraction forceps which is used to restore longitudinal length between the pedicle screws of l4 and l5, and the ¿ussii persuader¿, which is used to restore lordosis and dislocation of the spine in anterior direction.The following complications were reported as follows: 18 of the 24 patients required intensive care treatment for an average of 18.3 ± 10.0 days (range: 1¿35 days).Total length of stay ranged from 12 to 107 days, with a mean los of 35 ± 23 days.In 2 patients (8.3%), intra-/or perioperative surgical complications occurred: one patient developed respiratory deficiency immediately postoperatively, requiring intensive care treatment.In the second patient, a bleeding stemming from the dorsal sacral area occurred.Another 2 patients (8.3%) suffered from postoperative complications: one patient sustained a pulmonary embolism, whereas another patient developed a pneumonia and uti.50% of patients presented a mental illness and/or required psychiatric treatment during or after the hospitalization.Radiological imaging was performed postoperative, 6 weeks, 3 months, 6 months and 1 year after the operation.This is report 3 of 3 for (b)(4).This report is for an unknown synthes ussii construct.

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.This report is for an unknown ussii construct/unknown lot.Part and lot numbers 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 II
• Type of Device: ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION
• 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: 14979384
• MDR Text Key: 295639189
• Report Number: 8030965-2022-04704
• Device Sequence Number: 1
• Product Code: MNH
• 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
• Reporter Occupation: Physician
• 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