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

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

Patient Problems Paralysis (1997); Spinal Cord Injury (2432); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/01/2020

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).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: mladenov k., et al (2020)management of spinal deformities and tibial pseudarthrosis in children with neurofibromatosis type 1 (nf-1),child's nervous system volume 36, pages 2409¿2425 ((b)(6)).This retrospective study aims to present the results and describes our recommendations for the treatment of spinal deformities in pediatric patients with nf-1 based on our long-term experience in the management of these patients.Between 2006 and 2020, the clinical records, radiographs, and other imaging studies of all patients treated for spinal deformities associated with nf-1 were reviewed.Thirty-three patients fulfilled the inclusion criteria.Mean age at index surgery was 9.8 years (range 4.3¿ 16.6 years).A growth-preserving technique (gpt) as a stand-alone procedure was performed as the initial procedure in 11 patients: magnetic controlled growing rods (mcgr) n = 5, vertical expansion prosthetic titanium ribs (veptr) n = 6.The following complications were reported as follows: a case of an (b)(6) year old patient (pt.No 11) underwent revisions 3 times.A case of a (b)(6) year old patient (pt.No 12) underwent revisions 2x veptr.A case of a (b)(6) year old patient (pt.No 14) underwent revision , rib anchor.(due to aseptical loosening of the rib anchors in these cases, revision surgery was necessary.One of the five of the patients needed more than one revision surgery for mechanical issues.) a case of a (b)(6) year old patient (pt.No 18) underwent revision 4 times.A case of a (b)(6) year old patient (pt.No 30) underwent revision with a veptr device.A case of a (b)(6) year old patient (pt.No 31) underwent revision with a veptr device.Fig.7 (case 7) a case of an (b)(6) year-old nf-1 patient with moderate dystrophic scoliosis underwent index procedure comprised of a growth preserving technique by means of vertical expandable titanium ribs (veptr).The curve was well controlled and worsening was prevented for 4 years after initial surgery.During the pubertal growth spurt, significant curve progression occurred.An ¿in situ¿ posterior fusion combined with concave instrumentation was performed at age 13 on further follow-up, the curve increased significantly due to the ¿modulation¿ process of dystrophic alterations the patient developed an incomplete flaccid paraplegia of the lower extremities due to an increase of thoracic kyphosis resulting in anterior compression of the spinal cord.The treatment approach comprised of removal of instrumentation and halo gravity traction for 4 weeks.Followed by posterior and anterior spinal fusion postoperative x-rays showing good deformity correction.Mechanical complications occurred in 12 patients treated with gpt and were mostly due to aseptical loosening of the rib anchors in these cases, revision surgery was necessary.Five of the patients needed more than one revision surgery for mechanical issues.A total of two patients (n = 2) developed neurological symptoms.In the second patient, incomplete lower paraplegia developed 10 years after primary surgery for deformity correction.The deformity was treated by removal of the instrumentation and the application of hgt for a slow correction of kyphosis over 4 weeks followed by anterior and posterior spinal fusion and anterior strut grafting in the same surgical setting.Partial recovery of the paraplegia was observed 6 months after surgery.At latest follow-up, the patient was able to ambulate short distances with a posterior walker.In our series, one patient with cervical kyphosis and instability due to severe dystrophic changes showed delayed union and needed augmentation of the fusion mass.Solid fusion occurred at the latest follow-up.This report is for an unknown synthes vertical expansion prosthetic titanium ribs (veptr).This report is for one (1) unk - constructs: veptr.This is report 7 of 9 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: VEPTR
• Type of Device: PROSTHESIS, RIB REPLACEMENT
• 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: 11350845
• MDR Text Key: 242883115
• Report Number: 8030965-2021-01184
• Device Sequence Number: 1
• Product Code: MDI
• 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,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2021
• 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: 01/29/2021
• 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