MAUDE Adverse Event Report: SYNTHES (USA); PROSTHESIS, RIB REPLACEMENT

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/07/2010

Event Type  malfunction  

Event Description

This report is being filed after the subsequent review of the following journal article: ¿bilateral rib-to-pelvis technique for managing early-onset scoliosis¿.The purpose of the study was to describe a bilateral percutaneous rib-to-pelvis technique, present the author's early experience with this technique in patients with early-onset scoliosis, identify adverse events, and determine whether these are comparable to those for other current techniques.This was a retrospective review of 37 patients, 18 boys and 19 girls with early-onset scoliosis treated with the bilateral rib-to-pelvis vertical expandable prosthetic titanium rib (veptr) technique from 2003 to 2009.This technique utilizes bilateral veptr devices that are attached to the ribs proximally and to the pelvis distally using small incisions.This technique does not include an expansion thoracoplasty as part of the procedure.Patients were divided into 2 functional groups: eighteen ambulatory patients- 9 boys, 9 girls.Average age at the time of initial implantation was 6 years (range, 1.5-11.7 years) who underwent 139 procedures.The primary diagnoses in this group were early-onset scoliosis, neurofibromatosis type i, neuromuscular kyphosis, and kyphoscoliosis.Nineteen non-ambulatory patients - 9 boys, 10 girls.Average age at the time of initial implantation was 6.1 years (range, 1.4-10.9 years) who underwent 100 procedures.The primary diagnosis for the majority of the non-ambulatory group was neuromuscular disease.This is report 1 of 2 for (b)(4) and is for 19 unknown veptr constructs, for hook migration and/or failure of instrumentation (13 in the ambulatory group,revised at the time of scheduled revision and 6 in the non-ambulatory group).

Manufacturer Narrative

The study included 37 patients; 18 boys and 19 girls.The mean age was 6.1 years (range 1.4-11.8y).The patients were divided into 2 functional groups: eighteen ambulatory patients- 9 boys, 9 girls.Average age at the time of initial implantation was 6 years (range, 1.5-11.7 years) who underwent 139 procedures.The primary diagnoses in this group were early-onset scoliosis, neurofibromatosis type i, neuromuscular kyphosis, and kyphoscoliosis.Nineteen non-ambulatory patients - 9 boys, 10 girls.Average age at the time of initial implantation was 6.1 years (range, 1.4-10.9 years) who underwent 100 procedures.The primary diagnosis for the majority of the non-ambulatory group was neuromuscular disease.This report is for 19 unknown veptr constructs.Smith, j.(2010, december 7).Bilateral rib-to-pelvis technique for managing early-onset scoliosis.Clin orthop relat res, 469:1349-1355.Without a lot number the device history records review could not be completed.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.

• Type of Device: PROSTHESIS, RIB REPLACEMENT
• Manufacturer (Section D): SYNTHES (USA); 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES (USA)
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 3771337
• MDR Text Key: 4430987
• Report Number: 2520274-2014-10995
• Device Sequence Number: 1
• Product Code: MDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PH030009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/03/2014
• Initial Date FDA Received: 04/24/2014
• 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