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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Post Operative Wound Infection (2446)

Event Type  Injury  

Manufacturer Narrative

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.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

This report is being filed after the review of the following journal article: cahill, p.J.(2019), comprehensive wound risk stratification of rib-based distraction instrumentation procedures, spine deformity, vol.7, pages 971-978 (usa) the purpose of this study is to further identify factors predictive of veptr instrumentation wound complication and create a risk stratification model.Between january 2011 and september 2015, a total of 122 patients underwent 140 rib-based distraction (rbd) instrumentation.There were 76 males and 64 females with a mean age at surgery was 5.2 years.Implants used were unknown synthes veptrs.Of the 140 veptr devices implants, 26 patients were rib-rib, 87 patients were rib-pelvis, 27 patients were rib-spine.One patient underwent extensive vertebral fusion from the t2 vertebrae to the s2 vertebrae (yet had instrumentation with veptr).The following complications were reported as follows: 22 patients had wound complication.18 was infectious.4 was noninfectious.Intravenous antibiotics were not administered within one hour of incision in 4 of the 140 cases, with 1 case resulting in surgical site infection.The low incidence of mistimed administration of antibiotics prevented meaningful statistical analysis.10 of the wound complications occurred at the thoracotomy incisions, whereas 9 of the wound complications occurred at the iliac incisions.In 2 cases, wound complications developed at multiple incisions sites.2 wound complications occurred more than 90 days after surgery, these occurred at 97 and 138 days.1 patient experience 2 wound complications, each following a separate veptr implant procedure.The initial complication was treated with incision and drainage with implant retention.The second wound complication was treated with incision and drainage with implant removal.This report is for an unknown synthes veptr.

• Brand Name: UNK - CONSTRUCTS: VEPTR
• 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 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 11381984
• MDR Text Key: 241454791
• Report Number: 2939274-2021-01056
• 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: Physician
• Type of Report: Initial
• Report Date: 02/03/2021

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: 02/03/2021
• Initial Date FDA Received: 02/25/2021
• 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