MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC; PROSTHESIS, RIB REPLACEMENT

Device Problem Migration (4003)

Patient Problems Injury (2348); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Brand name, common device name, procode, mfr, lot #, part #, udi #, 510k: this report is for an unknown - veptr implants/unknown lot number.Without the specific part number, the udi number and 510k number is unknown.Device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).Device evaluated by mfr, manufacture date: without a lot number, the device history records review could not be completed as no product was received.Investigation summary 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: roye, b.Et al.(2017), comparison of complications and unplanned or visits between magnetically controlled growing rods and vertical expandable prosthetic titanium rib, spine deformity, vol.5, issue 6, pages 451-452 (usa).The purpose of this study is to compare complication risk and unplanned or visits between primary mcgr and veptr implants at 2-year follow-up from a single academic institution.A total of 52 patients were treated with an unknown synthes vertical expandable prosthetic titanium rib (veptr).The following complications were reported as follows: 10 patients had wound complications.4 patients had medical complications.20 patients had anchor migration (hook displacement, screw pullout, rib erosion).7 patients had miscellaneous implant complications (screw breach, curve progression, etc.).This is for an unknown synthes vertical expandable prosthetic titanium rib (veptr).This report is 3 of 4 for (b)(4).

• Type of Device: PROSTHESIS, RIB REPLACEMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 8886051
• MDR Text Key: 154257319
• Report Number: 2939274-2019-59736
• Device Sequence Number: 1
• Product Code: MDI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/16/2019
• 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