MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: VEPTR; PROSTHESIS, RIB REPLACEMENT

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

Patient Problem Physical Asymmetry (4573)

Event Type  Injury  

Event Description

This report is being filed after the review of the following journal article: hasler, c.C.(2018), early-onset scoliosis: contemporary decision-making and treatment options, journal of pediatric orthopaedics, vol.38 (6) pages s13-s20., (switzerland).The aim of this retrospective multicenter study was to predictably correct the coronal deformity, to foster trunk height and pft and to lower the burden of care for patients and families.Over the last 10 years the former variability in expert¿s opinion with regard to the choice of operative strategy and the timing of surgery has developed to a clearer decision-making algorithm with global advocacy.Serial plasters and bracing should be applied as long as deformities do not progress beyond 60-degree cobb angle to omit the complications associated with repeat surgery.Patients with tis benefit from early thoracic interventions with veptr.Half yearly expansions of dual growing rods constitute the standard method for eos in anatomically otherwise normal spines.Alternatively, other patients were treated with the growth-guiding shilla system including instrumented apical fusion and sliding anchor screws.Median follow-up is unknown.The following complications were reported as follows: a female patient with goldenhar syndrome originally presented with a congenital 90 degrees thoracolumbar kyphoscoliosis which was instrumented with veptr at the age of 6 years.Up to the age of 12 she underwent 12 half yearly open veptr expansions and successfully remodeled to a final 50-degree thoracolumbar kyphosis.She is ambulating independently and neurologically intact.Physiological sagittal balance resulted from final t2-l5 fusion at the age of 17 years.Within 6 months a partial collapse of the osteopenic anterior spinal column and the uninstrumented segment l5-s1 led to a 30-degree loss of lumbar lordosis which she could not compensate despite increasing pelvic tilt and knee flexion.A 30-degree l2 pedicle subtraction osteotomy and additional ileosacral fixation restored sagittal balance.At the 1-year follow-up she presents with a restored sagittal and coronal balance.This report is for unknown vertical expandable prosthetic titanium ribs (veptr), depuy synthes spine.A copy of the literature article is being submitted with this report.This is report 1 of 1 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.510k: this report is for an unknown veptr construct/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.The investigation could not be completed; no conclusion could be drawn, as no product was received.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: VEPTR
• Type of Device: PROSTHESIS, RIB REPLACEMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wrights lane east; west chester, PA 19380 ; 8472871282
• MDR Report Key: 16296952
• MDR Text Key: 308788701
• Report Number: 8030965-2023-01379
• Device Sequence Number: 1
• Product Code: MDI
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2023
• 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: 01/27/2023
• 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
• Patient Outcome(s): Required Intervention
• Patient Sex: Female