MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - SCREWS: LOCKING; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Device Problems Break (1069); Unintended Movement (3026)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown locking screw/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).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: bolesta, m.J., rechtine, g.R., and chrin, a.M.(2000), three- and four-level anterior cervical discectomy and fusion with plate fixation a prospective study, spine, vol 25.No.16, pages 2040-2046 (usa) 10.1097/00007632-200008150-00007.The objective of this study is to provide medium-term follow-up data on the surgical success and patient outcome of three- and four-level anterior cervical discectomies and fusions and to determine the effect that plate fixation has on the results.From july 1990 through september 1997, a total of 15 patients (5 males and 10 females) with an average age was 51 ± 12.4 years (standard deviation; range, 35¿77) underwent anterior fixation using an unknown synthes cervical spine locking plate.They had a minimum follow-up of 24 months.The following complications were reported as follows: 1 technical problem occurred during instrumentation.In one of the three-level procedures, 1 set screw could not be placed; this was not thought to be crucial.1 patients's plate loosened.1 patient had a fractured plate.2 patients had broken screws.1 plate pulled loose within the first 3 weeks of surgery.The plate was removed when the problem was recognized.Subsequently, all three levels fused without fixation, and the patient had no symptoms at 67-month follow-up.1 plate fractured 4 months after surgery.It was removed when the fracture was noted, and a posterior arthrodesis was performed while the patient was under the same anesthetic.The patient had no pain at 25-month follow-up.1 patient experienced serious dysphagia, but this resolved with conservative measures.2 patients with myelopathy had pain at follow-up.Noted improvement in the myelopathy.3 patients with radiculopathy, 1 were relieved of pain, but 2 others reported residual neck pain.5 patients underwent a 2nd cervical operation.5 patients had persistent nonprogressive pain at final follow-up.1 patient had adjacent segment degeneration, requiring anterior extension combined with posterior fusion 46 months after the original procedure.3 patients had some pain despite radiographic union.2 patients with degeneration at an adjacent level were symptomatic.8 patients had a nonunion of at least one level.1 patient had cervical or upper extremity pain at final follow-up.2 patients without pain needed a second procedure, which successfully yielded a painless arthrodesis.1 patient with non-union at last follow-up had pain due to pseudoarthrodesis.1 patient had a poor outcome.1 female patient had adjacent segment degeneration, requiring anterior extension combined with posterior fusion 46 months after the original procedure.Of incidental note, one of the screws in this patient was noted to be fractured 30 months after the initial surgery, even though solid fusion had been achieved before pain developed at another level.Extension of the fusion was radiographically successful, but she had some pain at 73 months.1 male patient ha a screw fracture 4 months after original surgery, but symptoms were mild.Two motor vehicle accidents worsened his pain.Posterior grafting 18 months after the initial operation resulted in bony union.The patient had no neck or arm pain 48 months after the index procedure, but he reported lumbar pain.1 female patient had nonunion without hardware failure, which healed with posterior fusion 24 months after the first operation; however, she continued to experience intermittent c6 radiculopathy at 50 months.1 male patient had cervical or upper extremity pain at final follow-up.He resumed cigarette smoking after the procedure.He wore a brace for 5 weeks.(b)(6) year-old woman had a fibrous nonunion at c6-c7 49 months after a four-level procedure.The hardware has settled and loosened but has not fractured.The radiculopathy resolved, and she is asymptomatic.(b)(4).This is for an unknown synthes locking screw.

• Brand Name: UNK - SCREWS: LOCKING
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• 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: 8940552
• MDR Text Key: 156452880
• Report Number: 2939274-2019-60162
• Device Sequence Number: 1
• Product Code: NKB
• 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: 07/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/31/2019
• 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