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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Ossification (1428)

Event Date 04/22/2014

Event Type  Injury  

Event Description

This report is being filed after the subsequent review of the following article: zivkovic, v., et al (2014).Extraspinal ossifications after implantation of vertical expandable prosthetic titanium ribs (veptrs).J child orthop 8:237-244.Four pediatric spine centers were involved in conducting a retrospective radiologic study on a subset of patients who underwent a veptr (vertical expandable prosthetic titanium rib) implantation at least 4 years previously, irrespective of the underlying diagnosis.The records of 65 veptr patients from the spine centers were analyzed.The average age of the 65 patients at the time of the index procedure was 6.5 years (minimum 1, maximum 13.7 years), and there was an almost balanced female: male ratio (31:34).The most prevalent underlying spine problem was a congenital scoliosis with multilevel malformations (37) and hemithorax constriction due to rib fusions (34/37), followed by neuromuscular and syndromic deformities (13 and 8, respectively).Idiopathic and secondary early-onset scoliosis was less frequent (3 and 4, respectively).All patients underwent a routine half-yearly expansion program, resulting in 7¿8 lengthening procedures during the 4-year observation period.No heterotopic ossifications were detected.In total, 42 of 65 (65%) patients showed at least one ossification.Half of the 119 ossifications occurred around the anchors.Almost half of the patients (15/33) without pre-existing congenital rib fusions developed an ossification along at least one of the rib sleeves of their rib-to-rib, rib-to-spine or rib-to-pelvic implants.The occurrence of ossifications was not statistically associated with patient-specific factors such as age, gender, underlying disease and the nature of the spinal deformity.Two-thirds of the patients showed ossifications, which was a slightly higher rate than previously reported.Half of those ossifications were situated around the anchors.Half of the patients without preexisting rib fusions developed ossifications along the implant overlying the ribs.Re-ossifications of thoracostomies were less frequent (15 %).Two patient¿s ossifications were specifically identified.A (b)(6)-year-old wheelchair-bound boy with neuromuscular scoliosis (myelomeningocele) 4 years after unilateral veptr implantation, was found to have a new bone formation at the ileum anchor point (type ic) and along the titanium rib at the thoracic level (iia) and the lumbar rod section (iib).Seven years after the index procedure there was an almost continuous bone mass along the implant, reaching from the rib cradle to the ala hook.Also, a (b)(6)-year-old boy with congenital scoliosis prior to the index procedure.Four years later, new bone formation along the rod section of the inner veptr constructs was suspected.Seven years later, a ct (at the age of (b)(6) years) confirmed the presence of ossifications at the level of the former lamina hook (ib) reaching over the caudal ribs (iia), and also at the level of the former upper rib cradle (ia).The thoracostomy remained open even after removal of the veptr.Based on those findings, a decision was made not to instrument and fuse the spine, since the situation was deemed stable.This study demonstrated that peri-implant ossifications are common in veptr patients.However, the multicenter and retrospective nature of the study leads to limitations such as data quality control, missing or inadequately collected data and variations in radiographic quality.This report is against an unknown veptr device concerning an ossification for the (b)(6) year old male.This is report 2 of 3 for (b)(4).A copy of the journal article is being submitted with this medwatch.

Manufacturer Narrative

The device was used for treatment, not diagnosis.The investigation could not be completed and no conclusion could be drawn, as no device was returned and no lot number or part number was 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: PROSTHESIS, 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: 4116852
• MDR Text Key: 4700727
• Report Number: 2520274-2014-13804
• 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: Foreign,Literature,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/19/2014

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/19/2014
• Initial Date FDA Received: 09/25/2014
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 16 YR