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 Problems Post Operative Wound Infection (2446); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

510k: this report is for an unknown veptr construct/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).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.

Event Description

This report is being filed after the review of the following journal article: cahill, p.J.Et al.(2020), correlation between surgical site infection and classification of early onset scoliosis (c-eos) in patients managed by rib-based distraction instrumentation, spine deformity, vol.8, pages 787-792 (usa).The aim of this study is to determine risk factors for infection among early onset scoliosis (eos) patients treated by rib-based distraction instrumentation, and to further assess the incidence of infection among c-eos categories and sub-types.Between 2013 and 2017, a total of 156 patients underwent 843 total rib-based distraction instrumentation procedures: 587 expansions, 179 revisions, and 77 implant surgeries.The average age at time of index procedure was 5 years, with patients ranging from 1 to 10 years.The following complications were reported as follows: 35 patients developed surgical site infections, as defined by the cdc, leading to 42 total cases complicated by infection among the 35 patients who suffered infections.Only three subjects underwent definitive treatment during the study period, none of whom developed subsequent ssis.14 patients of the 35 with infections ultimately had their implants removed following the ssi after failure to adequately control the infection.30 patients had staphylococcus aureus.22 patients had methicillin sensitive staphylococcus aureus (mssa).8 patients had methicillin resistant staphylococcus aureus (mrsa).Implant erosion was a significant risk factor for infection, with 38% of cases associated with a skin slough ultimately resulting in an ssi (11/29) compared with a 4% infection rate among cases with no skin slough.This report is for an unknown synthes veptr construct.It captures the reported adverse event of implant erosion associated with infection and skin slough.This is report 2 of 2 for (b)(4).

• 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 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 11392407
• MDR Text Key: 240742040
• Report Number: 2939274-2021-01076
• 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: distributor,literature,user f
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2021
• 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
• Date Manufacturer Received: 02/04/2021
• 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
• Patient Outcome(s): Required Intervention