MAUDE Adverse Event Report: SYNTHES GMBH UNK - MONO/POLYAXIAL SCREWS: USS II; ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION

Device Problem Migration (4003)

Patient Problem Hemorrhage/Bleeding (1888)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown uss ii mono/polyaxial screws/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k 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.

Event Description

This report is being filed after the review of the following journal article: ito, m.Et al (2010), simultaneous double-rod rotation technique in posterior instrumentation surgery for correction of adolescent idiopathic scoliosis, journal of neurosurgery: spine, vol.12 (xx), pages 293¿300 (japan).The aim of this study is to introduce the concept and surgical procedures of this new posterior surgery for correction of idiopathic scoliosis.A total of 6 female patients, with an average age of 13.4 years (ranged 9 to 19 years), were treated with simultaneous double-rod rotation technique (sdrrt).Surgery was performed using the uss ii polyaxial implant (synthes).The mean follow-up period was unknown.The following complications were reported as follows: a (b)(6)-year-old female patient had screw malpositioning observed on intraoperative imaging in the posteroanterior view, the screw at left t-10 was removed during surgery.The intraoperative blood loss was 1450 ml.An unknown number of patients had an intraoperative blood loss ranged from 250 to 2100 ml (mean 1150 ml).This report is for an unknown synthes uss ii mono/polyaxial screws.It captures the reported event of a (b)(6)-year-old female patient who had screw malpositioning observed on intraoperative imaging in the posteroanterior view, the screw at left t-10 was removed during surgery.The intraoperative blood loss was 1450 ml.This is report 1 of 3 for (b)(4).

• Brand Name: UNK - MONO/POLYAXIAL SCREWS: 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 ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 11748258
• MDR Text Key: 248077494
• Report Number: 8030965-2021-03432
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/06/2021
• 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
• Patient Age: 12 YR