MAUDE Adverse Event Report: SYNTHES GMBH UNK - LAMINA/PEDICLE/PROCESS HOOKS: USS; ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION

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

Patient Problem Unspecified Tissue Injury (4559)

Event Type  Injury  

Manufacturer Narrative

Additional narrative: this report is for an unknown lamina/pedicle/process hooks: uss/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.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

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: ricks m., clarke d., and davies e.(2019), a 5 year comparison study of the uss and urs / uss posterior instrumentation technique for idiopathic scoliosis correction, british journal of surgery, conference: international surgical congress of the association of surgeons of great britain and ireland, asgbi 2019.Vol.106 (supplement 5), pages 51-52 (united kingdom).The aim of this retrospective study is to compare 2 posterior fixation systems over a 5 year period.A total of 45 patients were treated with universal spinal system (uss group).In the urs/uss system group, 118 patients were included.All patients underwent posterior instrumentation for correction of idiopathic scoliosis.The mean follow-up period was unknown.The following complications were reported as follows: uss group: unknown number of patients had 6 complications reported.Urs/uss group: unknown number of patients had 22 complications reported.Unknown number of patients had dural tear following hook placement in the urs / uss and was surgically managed.This report is for an unknown synthes uss hooks.A copy of the literature article is being submitted with this medwatch.This is report 1 of 2 for (b)(4).

• Brand Name: UNK - LAMINA/PEDICLE/PROCESS HOOKS: USS
• Type of Device: ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 11745415
• MDR Text Key: 247954863
• Report Number: 8030965-2021-03417
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/26/2021

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2021
• 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