MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION

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

Patient Problems Unspecified Infection (1930); Ulcer (2274); Impaired Healing (2378); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown mono/polyaxial screws: uss/unknown lot.Part and lot number are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4): the reported event required medical/surgical intervention to preclude permanent damage to a body structure.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.Investigation summary product was not returned.Based on the information available, it has been determined that no corrective and preventive action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).

Event Description

This report is being filed after the review of the following journal article: carlo bellabarba, thomas a.Schildhauer, alexander r.Vaccaro, and jens r.Chapman, (2006), complications associated with surgical stabilization of high-grade sacral fracture dislocations with spino-pelvic instability, spine vol.31(11) pages s80-s88 (usa).The aim of this article is to evaluate and document these complication rates to gain further insight into the appropriate treatment of patients with high-energy sacral fracture dislocations and assist both injured patients and treating physicians in the informed risk-benefit decision-making process.Between 1997 to 2002, a total of 19 patients (11 male and 8 female) with a mean age of 32 years (range, 15-59 years) were included in the study.These patients were assessed specifically for the following adverse events; infection, wound healing, neurologic deterioration following surgical treatment, postoperative loss of sacral fracture reduction, instrumentation failure, axial lumbopelvic pain requiring further treatment and unplanned secondary surgery.The lumbar pedicle screw using a side-opening system (universal spine system was applied to the l5 and s1 segments where possible.).The mean duration of follow-up was 25 months.The following complications were reported as follows: there were 3 patients who requested instrumentation removal because of prominence of their iliac screws.There were 3 patients without bridging callus who had asymptomatic ilio-sacral screw loosening, most likely caused by preserved sacroiliac motion (figure 7).Early loosening of left iliosacral screw, despite the presence of lumbopelvic fixation (figure 7).1 patient had decubitus ulcer caused by screw prominence.1 patient who had infection, wound healing disruption, and instrumentation removal because of iliac screw prominence.2 patients who required surgical reexploration of their incisions because of seroma/pseudomeningocele formation.14 patients had traumatic dural tears or sacral root avulsions.1 patient had post traumatic weight loss associated with a lasting traumatic brain injury.3 patients had no discernible recovery (lack of bowel and bladder recovery was positively correlated with lumbosacral root transection).3 patients who listed their pain as being in the buttock region who remained on analgesic medication for a variety of injuries.5 patients had sexual dysfunction.2 patients had dysesthesia in the lumbosacral plexus distribution.(b)(6) year old male with denis zone 3 roy-camille type 3 injury had a lateral radiograph of the sacrum 9 months after surgery that shows the persistent extension deformity (fig.6) there were 10 other patients who were considered to have clinically relevant soft tissue contusions with lumbodorsal fascial degloving analogous to the morel lavalle lesion.8 patients (42%) required an unplanned secondary visit to the operating room.The most common indication for return to the operating room was impaired wound healing with or without infection.(b)(6) year old male with denis zone 3 roy-camille type 3 injury had a lateral radiograph of the sacrum 9 months after surgery that shows the persistent extension deformity (fig.6).6 of 19 patients had at least 1 broken rod between the lowest lumbar and most rostral iliac screw.There was 1 patient who had 2 broken rods (figure 7).This report is for a universal spine system, unk pedicle screw: uss, and unknown rods: uss this report captures: one (1) patient had decubitus ulcer caused by screw prominence.1 patient who had infection, wound healing disruption, and instrumentation removal because of iliac screw prominence.This report is for one (1) unk - mono/polyaxial screw this is report 1 of 5 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Type of Device: ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8533155
• MDR Text Key: 142544001
• Report Number: 2939274-2019-57579
• Device Sequence Number: 1
• Product Code: NKG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature,study
• Type of Report: Initial,Followup
• Report Date: 03/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/25/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention