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

Device Problem Break (1069)

Patient Problems Loss of Range of Motion (2032); Joint Disorder (2373); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

There are multiple patients.All known information is provided in the journal article.This report is for an unknown veptr construct/unknown lot.Part and lot number are unknown; udi number is unknown.Implant date: there are multiple unknown dates of implantation between 2006 and 2010.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.(b)(4).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: latalski, m., fatyga, m.And gregosiewicz, a.(2011), problems and complications in veptr-based treatment, ortopedia traumatologia rehabilitacja, vol.13 (no.5), pages 449-455 (poland).The aim of this study is to present the problems and complications occurring in the veptr-based operative treatment of spinal and thoracic deformities in early infancy.Between 2006 to 2010, a total of 12 children with a mean age of 5.25 years (range: 3-9 years), were treated using vertical expandable prosthetic titanium rib (veptr).The mean age at the index procedure (ip) was 5.25 years (range: 3-9 years).Each child underwent 4-10 procedures.Mean follow-up duration was 2.5 years (10 months-4 years).The following complications were reported: in four patients, the construct was modified during elective lengthening.One patient with ehler-danlos syndrome had subluxed hip due to an increasingly slanting pelvis.The patient underwent repositioning of the distraction pin from rib-lamina to rib-pelvis and correct centering of the femoral head.1 patient had prolonged healing of the operative wound.4 cases had signs of metallosis (tissue reaction to the metal).4 cases had rib fractures.1 case had a hip joint destabilization.Deformation progressed by over 10° in 2 children.One subject demonstrated further correction of more than 10° and 3 other patients maintained the post-ip correction of 0-9°as compared to the last examination.Pneumothorax was noted in two patients while attaching the rib cradles during the index procedure.4 patients required revision surgery to reposition the construct.2 patients had pulmonary oedema.2 patients required revision surgery to replace a broken implant.1 patient had a device breakage twice, which was removed due to an increasingly slanting pelvis and due to interference with scapular motion.1 patient had the ala hook perforated the iliac ala.The separated ribs fused again (twice).1 patient had the ala hook perforated the iliac ala.Patient developed a sternal fusion along the implant.3 patients had ala hook perforated the iliac ala.1 patient had a rib fractured by a rib cradle twice.This report is for an unknown synthes vertical expandable prosthetic titanium rib (veptr) construct.This is report 4 of 4 for (b)(4).

• 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: 8687076
• MDR Text Key: 147603912
• Report Number: 8030965-2019-65179
• Device Sequence Number: 1
• Product Code: MDI
• Combination Product (y/n): N
• Reporter Country Code: PL
• 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: 05/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2019
• 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: 05/14/2019
• 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