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

Device Problems Break (1069); Unintended Movement (3026)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Patient information is unknown.Waldhausen j.H.T., redding g., white k., song k.(2016).Complications in using the vertical expandable prosthetic titanium rib (veptr) in children.Journal of pediatric surgery.51: p.1747-1750.United states.Pma / 510k: this report is for an unknown veptr implant /unknown lot.Part and lot number are unknown; udi number is unknown.Implant date is unknown.Explant date is unknown.Without a lot number the device history records review could not be completed.The manufacture date is unknown.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 subsequent review of the following literature article waldhausen j.H.T., redding g., white k., song k.(2016).Complications in using the vertical expandable prosthetic titanium rib (veptr) in children.Journal of pediatric surgery.51: p.1747-1750.United states.The purpose of this report was to describe complications using the vertical expandable prosthetic titanium rib (veptr) for thoracic insufficiency syndrome (tis) at a single center.The report reviewed 65 patients implanted with rib-rib and or rib-spine veptr devices.Patients with fractures created prior to the year 2008 were implanted with veptr i; while those who gained their fractures after the year of 2008 were implanted with veptr ii.It is unknown the year patients gained their fractures, making it unknown which patients were implanted with which veptr type (i or ii).Of the 65 patients, 12 had migration of either the superior cradle hook or the inferior fixation.Two (2) had migration of the sacral s hook into the pelvis.The other 9 had migration of the superior cradle.Nine (9) patients experienced wound infections.Two (2) of these 9 patients required implant removal as a result.Another 2 patients experienced skin breakdown/dehiscence.One (1) patient developed a postoperative radiculopathy that resolved over time.Three (3) patients had implant fracture, 1 from the veptr itself and 2 from the intramedullary wire placement.Two (2) patients experienced persistent pain, 1 from a broken intramedullary wire, 1 from the veptr rubbing on the native rib.Two (2) developed progressive scoliosis and needed fusion.One (1) developed pneumonia and another had a postoperative seroma.One patient died during follow up due to osteosarcoma because of his oncologic disease.According to the author of the article, no complications were due to the veptr.Any veptr that broke according to the author, is most probably attributed to a child being active and doing what they normally do.This is report 1 of 2 for (b)(4).

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.(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: michael cote ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7251262
• MDR Text Key: 99351268
• Report Number: 2939274-2018-50547
• 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
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2018
• 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
• Date Manufacturer Received: 01/19/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention