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

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Failure of Implant (1924)

Event Date 12/31/2009

Event Type  Injury  

Event Description

This report is being filed after the subsequent review of the following article: efficacy and safety of veptr instrumentation for progressive spine deformities in young children without rib fusions hasler, c., et al (2010).Euro spine j 19: 400-408.This was a retrospective study that evaluated children treated with vertical expandable prosthetic titanium rib (veptr) for correction on non-congenital early onset spine deformities.Twenty-three patients (8 boys, 15 girls) were enrolled in the study.Diagnosis included 1 early onset idiopathic scoliosis, 11 neuromuscular, 2 post-thoracotomy scoliosis, 1 sprengel deformity, 2 hyperkyphosis, 1 congenital muscular dystrophy, 5 syndromic.The average age at the time of the index procedure (ip) was 6.5 years (1.11¿10.5 years).The ip was performed without rib osteotomies.After the ip, the device was lengthened at 6 month intervals.The average follow-up time was 3.6 years (2¿5.8 years).Radiographs and clinical photographs were taken at the time of ip and at every expansion procedure.Twenty-three ips, an average of 6.5 (4¿10) expansion surgeries per patient (total 149) and 15 unplanned surgeries were performed.Reasons for the unplanned surgeries include wound debridement, temporary implant removal due to infection, myocutaneous local flaps and refixation (due to loosening of anchor points) of implants.Dislodgements and breakages of implants were rated as complications if they led to extra surgery.Nine patients (nos.2,7,9,11,12,13,16,22,23) sustained 23 complications: 10 skin sloughs, 5 implant dislocations, 2 rod breakages and 6 deep infections.The article did not specify complications associated with all the identified patients.Eighteen implant-related events required seven unplanned interventions due to pain, skin slough or apparent loss of correction.The article did not identify patients who had the implant-related events.Two patients (nos.4, 20) had a more than 10°worse cobb angle at follow-up than before the ip.One lumbar extension rod and one ala hook broke (no.7).One hook was dislodged posteriorly in a kyphotic patient (no.9).The space available for lung ratio that was less than 90% prior to veptr had a deteriorated in one patient at follow-up (no.17).In eight patients, the construct was modified during routine surgery.Five times the construct was extended to the pelvis to counteract junctional kyphosis (nos.8, 22, 23) and pelvic obliquity with loss of balance (nos.4, 19).Additional constructs were used to unload a dislodging cradle (no.12, 5 year old, boy) and to treat an emerging compensatory upper thoracic curve (no.18).One rib-to-rib construct was removed for interference with scapular motion (no.15).Some neuromuscular patients ossified along the implant (nos.3, 4, 7, 11).One patient (no.1, 4-year old boy) had infantile scoliosis that progressed to 71° cobb angle at the lumbar main curve despite full time bracing.Also, this patient had congenital muscular dystrophy and a restrictive respiratory syndrome and needed a tracheostoma and home ventilation due to acute deterioration of her respiratory function.The authors concluded that veptr proved to be a valuable alternative to dual growing rods for non-congenital early onset spine deformities.The complication rate was lower, the control of the sagittal plane and the pelvic obliquity was as good, but the correction of the coronal plane deformity was less than growing rods.However, veptr¿s spine-sparing approach might provoke less spontaneous spinal fusion and ease the final correction at maturity.This report for patient no.9 who had revision surgery to repair one hook that was dislodged posteriorly.This is report 7 of 17 for (b)(4).This report is for: unknown veptr.The copy of the literature article is being submitted with this medwatch.

Manufacturer Narrative

Device used for treatment, not diagnosis.Date of event: efficacy and safety of veptr instrumentation for progressive spine deformities in young children without rib fusions hasler, c., et al (2010).Euro spine j 19: 400-408.This report is for an unknown veptr/unknown quantity/unknown lot.The investigation could not be completed and no conclusion could be drawn as no device was returned and no lot number or part number were provided.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Type of Device: PROTHESIS, RIB REPLACEMENT
• Manufacturer (Section D): SYNTHES(USA); 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4589438
• MDR Text Key: 19724985
• Report Number: 2520274-2015-11535
• Device Sequence Number: 1
• Product Code: MDI
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: PH030009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2015
• 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: 02/15/2015
• 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
• Patient Age: 2 YR