MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH; PROSTHESIS, RIB REPLACEMENT

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Bone Fracture(s) (1870); Failure of Implant (1924)

Event Date 10/06/2017

Event Type  Injury  

Manufacturer Narrative

This report is for unknown vertical expandable prosthetic titanium rib (veptr) implant.Part and lot numbers are unknown.Without the specific part and lot number; the udi number is not available.Implanted/explanted date: unknown.Complainant device is not expected to be returned for manufacturer review/investigation.Pma / g5 (510k#): unknown.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.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 subsequent review of the following literature article chen, z.And et al.(2017) evolution of the postoperative sagittal spinal profile in early-onset scoliosis: is there a difference between rib-based and spine-based growth-friendly instrumentation?.J neurosurg pediatr, volume 20: 561-566.(china).The purpose of this article is to compare the effects of vertical expandable prosthetic titanium ribs (veptr) and growing rod instrumentation (gri) constructs on the sagittal profile of the early-onset scoliosis (eos) population and to demonstrate the complications related to changes in sagittal alignment during the lengthening period.This retrospective study included two groups.There were eleven (11) patients in the veptr group that consist of eight (8) boys and three (3) girls and twenty-two (22) patients in the gri group which consist of sixteen (16) boys and six (6) girls.In the veptr group, 7 patients had dual rib-to-spine rods, while 4 had a single rib-to-spine rod, accompanied by unilateral rib-torib constructs in 2 of the 4.In the gri group, there were 7 patients with a single rod and 15 patients with dual rods.Inclusion criteria for both groups were age of 10 years or younger at the time of index surgery, main thoracic curve scoliosis, at least 3 lengthening procedures, and follow-up duration of more than 2 years.Complication: one (1) patient (male, 3.4 years) experience right-sided rib cradle migration in the veptr group.Three (3) unknown patient experience rib cradle migration with or without rib fracture in the veptr group.Two (2) unknown patient had pedicle screw, hook, or rod dislodgement in the veptr group.Two (2) unknown patient had proximal junctional kyphosis (pjk), as a major alignment-related complication in the veptr group.One (1) unknown patient had sagittal imbalance in the veptr group.One (1) unknown patient had underwent implant removal as a result of deep infection 9 months after the fourth lengthening procedure in the veptr group.This report is for unknown vertical expandable prosthetic titanium rib (veptr) implant.This report is for three (3) unknown patient experience rib cradle migration with or without rib fracture in the veptr group.This is report 2 of 5 for complaint (b)(4).

• Type of Device: PROSTHESIS, RIB REPLACEMENT
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7248639
• MDR Text Key: 99303210
• Report Number: 8030965-2018-50918
• Device Sequence Number: 1
• Product Code: MDI
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2018
• 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: 01/17/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention