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

Device Problem No Apparent Adverse Event (3189)

Patient Problem Pain (1994)

Event Date 05/08/2019

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown constructs: veptr/unknown lot.Part and lot numbers are unknown; udi number is unknown.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: lieber, j., kirschner, h.J., and fuchs, j.(2012), chest wall repair in poland syndrome: complex single-stage surgery including vertical expandable prosthetic titanium rib stabilization ¿ a case report, journal of pediatric surgery, vol.47, pages e1-e5 (germany).The objective of this study were the establishment of better thoracic organ protection and elimination of visible lung movement.This study presents a case report of a (b)(6) year old boy with poland syndrome without limb involvement presented with paradoxical movement of the right chest wall skin in the region of the defect, subjective perception of respiratory compromise during stress, and cosmetic as well as psychologic concerns.Computed tomography (ct) of the chest showed a dysmorphic hypoplastic right pectoralis major and rudimentary pectoralis minor muscles, allowing the right lung to bulge toward the skin.A surgical intervention was obtained and under general endotracheal anesthesia, an s-shaped horizontal incision was made in the area of the deformity.The manubrium was deformed, and the sternum shortened and derotated, resulting in a left-sided rib buckle.Stable refixation was achieved by transsternal/transcostal k-wire insertion and bending of the k-wire on both sides.Postoperative pain was controlled with an epidural catheter; healing was uneventful.Scostal k-wire insertion and bending of the k-wire on both sides.However, the rib maintained fixation underneath the muscle flap and permacol patch.Partial metal removal (k-wires) was performed on postoperative day 90.There were no other complications.At the latest clinical and radiologic follow-up examination 9 months after operation, the patient was very pleased with the cosmetic result, no longer complained about respiratory compromise during exercise, and did not report any impairment with moving.The following complication was reported as follows: postoperative pain was controlled with an epidural catheter; healing was uneventful.This report is for a vertical expandable prosthetic titanium rib (veptr) (synthes).This is report 1 of 1 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: VEPTR
• 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: 8883125
• MDR Text Key: 153975137
• Report Number: 8030965-2019-67102
• 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: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 07/15/2019
• Initial Date FDA Received: 08/12/2019
• 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
• Patient Age: 16 YR