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

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.The study included 51 males, 44 females and 11 patients whose genders were unknown, totaling up to 106 children patients.Patients information not provided for reporting.The 510k: this report is for an unknown unk - veptr implants/unknown lot.Part and lot number are unknown; udi number is unknown.Implant & explant dates are unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).: the literature article indicated that all of the patients experienced implant failure post-op.The exact cause of the implant failure in the patients in the study is not mentioned in the article.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 park et.Al (2017) the classification for early-onset scoliosis (c-eos) correlates with the speed of vertical expandable prosthetic titanium rib (veptr) proximal anchor fracture.J pediatr orthop.37:6, p.381-386.Usa.The purpose of this study was to assess the possible correlation between c-eos classification and the speed (failure/unit time) of vertical expandable prosthetic titanium rib (veptr) proximal fixation failure.The study included 51 males, 44 females and 11 patients whose genders were unknown, totaling up to 106 children patients all with a diagnosis of eos.These patients were than split into a total of 26 groups depending on their c-eos classification and implanted with a veptr device (synthes co., (b)(4)) as treatment.As time went on the researches monitored each patient measuring the speed/time in which it took the device to fail.The amount of time was than defined by three group types, high-speed, medium-speed, and low-speed.High-speed meant that the implant failed quicker than expected, medium-speed meant the implant failed in an average/expected amount of time and lastly, low-speed meant the implant took some time to fail.Eventually ever implant failed and was placed in a speed group.The cause of the implant failure in these patients is not mentioned in the article.The authors only focus on the speed of the failure.However, it is mentioned in the article that most veptr implants ¿fixation points migrate or fail with high frequency depending on the stresses on the construct, bone quality, and duration of attachment.¿ (b)(4).This complaint involves unknown veptr.One for all patients experiencing implant failure.

• 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 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7268793
• MDR Text Key: 99984920
• Report Number: 2939274-2018-50623
• 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,litera
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/23/2018

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: 01/23/2018
• Initial Date FDA Received: 02/13/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention