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 Adhesion(s) (1695); Bone Fracture(s) (1870); Pleural Effusion (2010); Post Operative Wound Infection (2446)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Pma/510k: this report is for an unk - constructs: veptr/unknown lot.Part and lot numbers are unknown; udi 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 as no product was received.The investigation could not be completed and no conclusion could be drawn at the time of filing this report.Product was not returned.Based on the information available, it has been determined that no corrective and 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

Device report from synthes reports an event in germany as follows: this report is being filed after the review of the following journal article: berger-groch, j., et al.(2020), vertical expandable rib-based distraction device for correction of congenital scoliosis in children of 3 years of age or younger: a preliminary report, journal of pediatric orthopedics, vol.40, number 8, pages e728-e733 (germany).The present study evaluates the outcome of children with congenital scoliosis associated with fused ribs after veptr implantation before the age of 3.From september 2007 to june 2018, a total of 13 children (7 males and 6 females with a manage at initial surgery of 24.4±10.6 months) with congenital scoliosis were treated with veptr.During index surgery, 6 patients were implanted with 1 unilateral veptr, 4 patients were implanted with 2 unilateral veptrs, 2 patients were implanted with a bilateral single veptr.One patient was initially implanted with a single veptr on one side and 2 on the other.Implant used was a veptr; depuy synthes spine, raynham, ma.The follow-up period was 91.5±23.1 months (61 to 130 months).The following complications were reported as follows: 1 child died during induction of anesthesia from massive cardiac comorbidity and was therefore excluded from the study.The first patient sustained a disorder of early wound healing, with imminent perforation of the implant, necessitating revision, and hook displacement.The second patient developed skin perforation in the distal part of the veptr.A third patient required revision for a displaced cradle.In 2 of 13 patients, the veptr device had to be exchanged because the maximal distraction had been reached.In those 2 cases, only one medical device was used.In 1 patient, an additional detethering procedure was performed because of a tethered spinal cord syndrome.Case for revision within planned 6-mo cycle: 16 patients had expired length of distraction distance, 5 patients had lamina hook loose, 6 patients had cradle loose, 2 patients had conversion from rib/rib to rib/lamina, 2 patients had conversion to rib/pelvis, 1 patient had pelvis hook loose, 1 patient had partial removal veptr, 1 patient had total removal veptr, 2 patients had new veptr after halo, 3 patients had partial spondylodesis, 1 patient had spondylodesis, 2 patients had imminent perforation with need for explantation, 1 patient had hemiepiphysiodesis c5-c7, 1 patient had reimplantation veptr.Early complications: 9 patients had pleural effusion, 1 patient had intraoperative rib fractures, 1 patient had superficial wound infection.Late complications: 8 patients had heterotopic ossifications, 3 patients had adhesion of the scapula, as proximal junctional kyphosis (pjk) developed in 2 patients, halo-gravity traction was applied, followed by revision and addition of more proximal anchors.In one of these patients, this had to be carried out no less than 4 times.This report is for an unknown synthes veptr.This report is for (1) unk - constructs: veptr.This is report 3 of 8 (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 ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 11391748
• MDR Text Key: 244302821
• Report Number: 8030965-2021-01425
• 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,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2021
• 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: 02/04/2021
• 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