MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - VEPTR IMPLANTS: SUPERIOR CRADLE; PROSTHESIS, RIB REPLACEMENT

Device Problem Migration (4003)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

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

It was reported that the patient underwent a bilateral revision of superior cradle surgery with the vertical expandable prosthetic titanium rib (veptr) on (b)(6), 2019, due to the superior cradle was sitting too superior.The construct was a rib-pelvic construct.All implants needed to be removed were removed successfully.The surgery was completed with no adverse consequence to the patient.Concomitant devices reported: closure for extension bar (part unknown, lot unknown, quantity unknown); proximal extension bar (part unknown, lot unknown, quantity unknown); distal extension (part unknown, lot unknown, quantity unknown); parallel connector (part unknown, lot unknown, quantity unknown); ala hook (part unknown, lot unknown, quantity unknown) this report is for an unknown veptr superior cradle.This is report 1 of 1 for (b)(4).

• Brand Name: UNK - VEPTR IMPLANTS: SUPERIOR CRADLE
• 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: 9535770
• MDR Text Key: 187696543
• Report Number: 2939274-2019-62809
• 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: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/03/2019

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/03/2019
• Initial Date FDA Received: 12/31/2019
• 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