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

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

Patient Problems Impaired Healing (2378); Spinal Cord Injury (2432)

Event Type  Injury  

Event Description

Literature articled received.This report is being filed after subsequent review of the following literature article: gauthier, l, et al (2014).Perioperative neurologic injury associated with rib-based distraction surgery.Spine deformity, 2, 481-488.Canada.There was a retrospective review of the children¿s spine study group database from 2004-2013.The researchers used the chi-squared test to compare the distributions of portions between diagnoses.The inclusion criteria were any rib-to-rib or spine-to-rib instrumentation.Growing rods without rib based attachments were excluded.A total of 524 patients were identified who were treated with rib-based distraction surgery.Nine neurologic injuries were identified in these patients (7 clinical and 2 neuro-monitoring alerts) for a neurologic injury rate of 1.7%.Using the classification for early-onset scoliosis, 8 patients were classified as congenital and 1 as neuromuscular.At the time of injury, the mean age was 4.1 +/- 2.2 years, the mean scoliosis was 66.3° +/- 21.9°, and the mean kyphosis was 43.5° +/- 36.9°.All of the injuries occurred at the time of initial implantation, with the exception of 1 patient in whom injury occurred during revision surgery.There were no injuries identified during routine lengthening surgery.There were no complete spinal cord injuries and most involved injury to the brachial plexus.Two patients counted as having a neurologic injury had changes in neuromonitoring only but no deficits existed on post-operative clinical exams.Of the other 7 with clinical injuries, only 2 had a neuromonitoring alert.Four patients required return to surgery and 1 needed intraoperative intervention.At the 4.2 years¿ follow-up, 7 of 9 patients had full resolution of symptoms and 2 patients had residulal upper extremity weakness.This report refers to patient # 1.Patient 1 was (b)(6) at the time of the event.This event occurred during a revision surgery.Patient 1¿s primary diagnosis was congenital scoliosis with fused ribs and their secondary diagnosis was diastematomyelia/diplomyelia tethered cord.Patient 1¿s construct levels were as follows: medial ~t3/4 pelvis; lateral ~t4- t10.Patient 1 experienced unilaterial leg weakness due to cord distraction with tethered cord.Patient 1¿s course of action was to return to surgery for removal of pelvis-to-rib device (postoperative day 1) and recovered from their injury.This is report 1 of 9 for (b)(4).This report is for an unknown vertical expandable prosthetic titanium rib (veptr) contstruct, unknown part #/lot #.

Manufacturer Narrative

The investigation could not be completed and no conclusion could be drawn, as no device was returned and no lot number for 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.(b)(4).

• 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: 4593188
• MDR Text Key: 18662442
• Report Number: 2520274-2015-11483
• 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: 02/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2015
• 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
• Date Manufacturer Received: 02/24/2015
• 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: 7 YR