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

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

Patient Problem Nerve Damage (1979)

Event Type  Injury  

Event Description

This report is being filed after the subsequent review of the following literature article skaggs, d., & et al.(2009).Efficacy of intraoperative neurologic monitoring in surgery involving a vertical expandable prosthetic titanium rib for early-onset spinal deformity.The journal of bone and joint surgery (91) 1657-63.Data was collected prospectively during a multicenter study.Surgical procedures were divided into three categories: primary device implantation, device exchange, and device lengthening.Further retrospective evaluation was undertaken in cases of neurologic injury or changes detected with neuromonitoring.There were 1,736 consecutive veptr procedures at six centers: 327 (in 299 patients).Consisted of a primary device implantation, 224 were a device exchange, and 1185 were a device lengthening.Perioperative clinical neurologic injury was noted in eight (0.5%) of the 1,736 cases: these injuries were identified after five (1.5%) of the 327 procedures for primary device implantation, three (1.3%) of the 224 device exchanges, and none of the 1185 device-lengthening procedures.Of the eight cases of neurologic injury, six involved the upper extremity and two involved the lower extremity.The neurologic deficit was temporary in seven patients and permanent in one patient, who had persistent neurogenic arm and hand pain.Intraoperative neuromonitoring demonstrated changes during six (0.3%) of the 1,736 procedures: five (1.5%) of the 327 procedures for primary device implantation and one (0.08%) of the 1,185 device-lengthening procedures.The neurologic injury involved the upper extremity in six patients and the lower extremity in two.There were five brachial plexopathies (with four involving both motor and sensory deficits).One case resolved by six months; one, by ten months; and two more, by one year.The remaining patient had resolution of all motor deficits but had persistent neurogenic arm and hand pain four years after the surgery.One child had hypersensitivity in both hands for six months.One child had dense motor deficits in both lower extremities noted during the wake-up test.Distraction was released and the lower implants were removed, resulting in a complete return of motor function postoperatively.One child had monoplegia of the left lower extremity noted during the wake-up test.In this patient, the dura and spinal canal had been inadvertently violated during the thoracostomies, resulting in incomplete injury of the spinal cord.Recovery was almost full by three years.Of the eight cases of neurologic injury in the perioperative period, five occurred in patients with a kyphosis of >50.One of these patients had lower-extremity involvement.All eight cases of clinical neurologic injury occurred in the latter phase.Neurologic injury during veptr surgery occurs much more frequently in the upper extremities than in the lower extremities.The rates of potential neurologic injuries (neurologic injuries plus instances of changes detected by monitoring) during primary implantation of the veptr (2.8%) and during exchange of the veptr (1.3%) justify the use of intraoperative neuromonitoring of the upper and lower extremities during those procedures.As neuromonitoring did not demonstrate any changes in children without a previous veptr-related monitoring change and there were no neurologic injuries during more than 1000 veptr-lengthening procedures, intraoperative neuromonitoring may not be necessary during those procedures in children without a history of a neurologic deficit during veptr surgery.This report is against 1 veptr device regarding a (b)(6) child who experienced brachial plexopathy (motor + sensory).This report is 3 of 8 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Skaggs, d., & et al.(2009).Efficacy of intraoperative neurologic monitoring in surgery involving a vertical expandable prosthetic titanium rib for early-onset spinal deformity.The journal of bone and joint surgery (91) 1657-1663.This report is for unknown veptr and unknown lot number.(b)(6).The investigation could not be completed and no conclusion could be drawn, as no device was returned and no lot or part numbers 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: 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: 4591584
• MDR Text Key: 5485667
• Report Number: 2520274-2015-11647
• 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: 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?: No
• 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: 120 MO