MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - VEPTR IMPLANTS: LAMINA HOOK; PROSTHESIS, RIB REPLACEMENT

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

Patient Problem Wound Dehiscence (1154)

Event Date 10/21/2015

Event Type  Injury  

Manufacturer Narrative

510k: this report is for an unknown veptr: implants: lamina hook/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.[(b)(4)].

Event Description

This report is being filed after the review of the following journal article: balioglu, mb.Et al (2015), the effect of vertical expandable prosthetic titanium rib on growth in congenital scoliosis, journal of craniovertebral junction & spine, vol.6(4), pages 200-205 (turkey) doi: 10.4103/0974-8237.167882.The purpose of this retrospective study is to evaluate the overall results of the veptr treatment on the growing spine; and the midterm results of the curve correction, thoracic height, space available for the lung (sal), coronal and sagittal balance, in the patients with congenital scoliosis accompanied by a thoracic deformity.Between 2009 and 2010, a total of 4 female patients with a mean age of 53 months (range, 20-79 months) were treated with (veptr¿ ; synthes spine co, west chester, pa).Veptr was applied on the ribs proximally and was applied on the ribs, the spinal column or pelvis distally.In all patients, veptr was applied unilaterally.Expansions were performed with a mean interval period of 8.4 months (range: 7.3-9.2).The total follow-up period was 5.8 years.The following complications were reported as follows: please refer all complications to table 1 and 2 (doi: 10.4103/0974-8237.167882).A female patient with management of rib to lamina veptr with thoracostomy, rib to rib veptr, veptr device was removed for final fusion.This patient had complications of the proximal rib fracture (revision of veptr) and had wound débridement.This patient had a rod fracture.A female patient with management of rib to lamina veptr with thoracostomy, revision of the pelvic hook (due to distal laminar hook insufficiency), revision of veptr performed as rib to rib with thoracostomy, rib to pelvic veptr was changed with growing rod.This patient had wound debridement (revision of the veptr).A female patient with management of rib to lamina veptr.This patient had a complication of distal hook failure (revision of the veptr).A female patient with management of rib to rib veptr, rib to lamina veptr (caudal rib anchor was changed with laminar hook), veptr was removed and later posterior instrumentation with fusion was performed.This patient had complication of distal rib fracture and anchor insufficiency.This report is for a female patient who had wound debridement (revision of the veptr).This report is for an unknown synthes veptr: implants: lamina hook.This is report 2 of 4 for (b)(4).

• Brand Name: UNK - VEPTR IMPLANTS: LAMINA HOOK
• Type of Device: PROSTHESIS, RIB REPLACEMENT
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 8750646
• MDR Text Key: 149712127
• Report Number: 8030965-2019-65932
• Device Sequence Number: 1
• Product Code: MDI
• Combination Product (y/n): N
• Reporter Country Code: TU
• 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: 06/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2019
• 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: 06/06/2019
• 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