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 Hematoma (1884); Non-union Bone Fracture (2369); Physical Asymmetry (4573)

Event Type  Injury  

Manufacturer Narrative

Product complaint #:(b)(4).This report is for an unk - constructs: uss ii/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 as no product was received.The investigation could not be completed, no conclusion could be drawn at the time of filing this report.The product was not returned.Based on the information available, it has been determined that no corrective and 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: this report is being filed after the review of the following journal article: balling, h.And weckbach, a.(2020), demineralized bone matrix versus autogenous bone graft for thoracolumbar anterior single-level interbody fusion, acta orthopaedica belgica, vol.86 (e-supplement 2), pages 6-16 (germany).The aim of this single-centre, prospective randomized controlled study is to compare the results of dbm putty plus titanium cage with those of autologous icbg for thoracolumbar fractures requiring anterior single-level fusion in a limited study-size.For 26 months, a total of 30 patients underwent posterior bi-segmental instrumentation and anterior stabilization by (i) titanium cage with dbm putty in 15 patients (trial group; 9 male and 6 females; mean age = 40.9±11.9 years), or (ii) autogenous icbg in 15 patients (control group; 8 male and 7 females; mean age = 45.5±12.0 years).For anterior stabilization, a titanium cage (synmesh, synthes inc., oberdorf, switzerland) was used.All individuals additionally received anterolateral single-level locking plate fixation (telefix, synthes inc., oberdorf, switzerland).Posterior internal fixation was performed percutaneously in 2 individuals of the trial, and 7 individuals of the control group using a competitor device.In the other cases, open reduction and internal fixation was conducted (uss ii, synthes inc., oberdorf, switzerland).The mean follow-up period was unknown.The following complications were reported: 6 control group cases had pseudarthrosis of the graft and the intervertebral result showed non-bridging.6 control group cases had non-union.In an unknown number of patients, the vas spine score was 68±20 and 65±17 at 3-6 months follow-up; 77±17 and 73±16 at 9 months follow-up for trial and control group, respectively.In an unknown number of patients, the loss of correction (loc) was -1.4±2.1 and -1.6±4.1 for trial group and control group, respectively.1 patient had post-surgical hematothorax indicating re-thoracotomy two days after anterior stabilization.1 patient had symptomatic pneumothorax after chest tube removal requiring chest re-drainage.1 patient had subfascial hematoma after posterior instrumentation indicated revision surgery.2 patients had pedicle screw misplacements needing correction.Patient 1: a (b)(6) female patient had non-union.Patient 2: a (b)(6) male patient had inferior non-union and non-bridging of intervertebral site.Patient 3: a (b)(6) male patient had inferior non-union and non-bridging of intervertebral site.Patient 6: a (b)(6) male patient had inferior non-union and non-bridging of intervertebral site.Patient 13: a (b)(6) female patient had bipolar non-union and non-bridging of intervertebral site.Patient 15: a (b)(6) female patient had non-union and non-bridging of intervertebral site.Patient 18: a (b)(6) male patient had non-union and non-bridging of intervertebral site.Patient 26: a (b)(6) male patient had superior non-union and non-bridging of intervertebral site.This report is for an unknown synthes synmesh, unknown synthes telefix, unknown synthes uss ii constructs, and unknown synthes mono/polyaxial screws.A copy of the literature article is being submitted with this medwatch.This report is for (1) unk - constructs: uss ii.This report is 3 of 10 (b)(4).Related product complaint: (b)(4).

• 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: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 11880641
• MDR Text Key: 266416967
• Report Number: 8030965-2021-04256
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2021
• 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: 04/27/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention