MAUDE Adverse Event Report: SYNTHES GMBH UNK - RODS: TROLLY; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Device Problem Material Integrity Problem (2978)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Event Description

Device report from synthes reports an event in canada as follows: this report is being submitted after review of a clinical study report evaluating growth guiding construct vs.Standard dual growing rods and veptr for the treatment of early onset scoliosis patients: a prospective multi center cohort study with a matched historical control: an interim report of demographics, pulmonary function, and adverse events.Analysis years 2015-2019.Adverse events were as followed: curve regression / recurrence of deformity.Worsening pulmonary function.Reduction of traction.Reduction in motor evoked potentials (meps) during surgery.Fatigue band break.Concerns about lung function; pfts unchanged.Outgrown trolley construct.Intraoperative neuromonitoring loss; trolley implanted 10 days later.Mep loss during surgery.Implant loosening.Change in curve morphology.Change in shoulder balance.Three cases required reoperation: one for curve regression, one because the patient outgrew the construct, and one because the implant loosened.This report involves one unk - rods: trolly.(b)(4) is related to (b)(4).(b)(4) captures additional patients from the same study.This is report 9 of 12 for (b)(4).

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.D1, d2a, d2b, d3, d4, g4 - 510k: this report is for an unknown rods: trolly /unknown lot.Part and lot numbers are unknown; udi number is unknown.D9: complainant part is not expected to be returned for manufacturer review/investigation.H3, h4, h6: 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 - RODS: TROLLY
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16775397
• MDR Text Key: 313635966
• Report Number: 8030965-2023-04973
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2023
• 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: 04/20/2023
• 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
• Treatment: UNK - TROLLEY SCREWS
• Patient Outcome(s): Required Intervention