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

Device Problem No Apparent Adverse Event (3189)

Patient Problems Pain (1994); Impaired Healing (2378); Reaction (2414)

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: rentea, r.M.Et al (2013), complications in the use of negative pressure wound therapy in pediatric patients, ortopedia traumatologia rehabilitacja, vol.13 (no.5), pages 449-455 (usa).The aim of this irb-approved single-institution retrospective study is to evaluate the effectivity of npwt in adjunct to wound healing and closure in the pediatric population.Between 2007 to 2011, a total of 304 patients with a mean age of 12.5 years (range = 0 to 18) and an average weight of 45.3kg (range 1.1 to 177kg) were included in the study.Surgery was performed using vertical expandable prosthetic titanium rib (veptr) or other fixators.Therapy was utilized with a median of 9 days per patient with 2 dressing changes.The following complications were reported as follows: 9 patients died.In 15 wounds, a hardware (veptr) was exposed, with 3 devices removed for infection control.56 patients had bone exposure.8 patients had complication, which includes 4 enterocutaneous fistulae.24 patients experienced unsuccessful therapy, pain, failure of the wound to progress, devitalized skin edges.107 patients had delayed primary closure of wound post-npwt.This report is for an unknown synthes vertical expandable prosthetic titanium rib (veptr).This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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.

• Type of Device: PROSTHESIS, RIB REPLACEMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8734924
• MDR Text Key: 149205009
• Report Number: 2939274-2019-58847
• Device Sequence Number: 1
• Product Code: MDI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/31/2019

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
• Initial Date Manufacturer Received: 05/31/2019
• Initial Date FDA Received: 06/26/2019
• Supplement Dates Manufacturer Received: 06/26/2019
• Supplement Dates FDA Received: 06/27/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention