MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC; PROSTHESIS INTERVERTEBRAL DISC

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

Patient Problems Unspecified Infection (1930); Nerve Damage (1979); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

510k: this report is for an unknown plate/unknown lot.Part and lot numbers are unknown; udi number is unknown.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative 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: rasouli a, cuellar j, kanim l, delamarter r (2018).Multiple-level lumbar total disk replacement a prospective clinical and radiographic analysis of motion preservation at 24¿72 months.Clinical spine surgery.Volume 00.Page 1-5.(usa) this study aims to demonstrate the clinical efficacy and biomechanical performance of multilevel lumbar total disk replacement (tdr) (2¿4 levels) at up to 72 months of follow-up.A total of 159 consecutive patients with degenerative disk disease who underwent multiple-level lumbar tdr for received 367 unknown synthes prodisc-l total disk replacement.89 were males and 70 were females.The average age was 41 years (range, 27-66 years).Patients were placed into a ¿multilevel group¿ according to the number of adjacent disk replacements: 2-level, 3-level, or 4-level tdr (tdr- 2, tdr-3, or tdr-4).The tdr-2 group has a total of 114 patients wherein 100 received tdr at l4¿l5/l5¿s1 and 1k4 received tdr at l3¿l4/l4¿l5.The tdr-3 group has a total of 41 patients wherein 38 received tdr at l3¿l4/l4¿l5/l5¿s1 and 3 received tdr at l2¿l3/l3¿l4/l4¿l5.The tdr-4 group has a total of 4 patients who received tdr at l2¿l3/l3¿l4/l4¿l5/l5¿s1.All patients had a minimum of 24 months of follow-up, with complete radiographs and clinical questionnaires for each follow-up time-point.Complications were reported as follows: 1 patient had a removal of prostheses and anterior/posterior fusion from l4¿s1 after severe trauma-related vertebral fracture and device dislocation at l5¿s1.1 patient had a continued back pain and underwent revision with posterior instrumented dynamic stabilization from l4¿s1.1 patient underwent revision with l2¿s1 posterior instrumented fusion for continued back pain.4 patients had postoperative lower extremity radiculopathy on the left side.These were thought to be secondary to the left-sided retroperitoneal approach.All resolved within 6 months of surgery.4 patients had deep venous thrombosis within 3 weeks of surgery.There were no embolic complications from the thrombotic events.1 patient had a superficial infection of the abdominal incisional wound which required operative debridement and oral antibiotics.The deep tissues and implant were not affected and there were no long-term sequelae from the infection.This report is for one (1) unknown¿ artificial disc replacement: prodisc l, polyethylene inlay this is report 5 of 6 for (b)(4).A copy of the literature article is being submitted with this medwatch.

• Type of Device: PROSTHESIS INTERVERTEBRAL DISC
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 8158060
• MDR Text Key: 130177027
• Report Number: 2939274-2018-55383
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2018
• 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: 11/22/2018
• 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