MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - CAGE/SPACERS: CONTACT FUSION; ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION

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

Patient Problems Pain (1994); Stenosis (2263); Post Operative Wound Infection (2446); Unspecified Tissue Injury (4559)

Event Type  Injury  

Manufacturer Narrative

There are multiple patients all information is provided in the article.This report is for an unknown contact fusion cage/spacers/unknown lot.Part and lot number are unknown; udi number is unknown.Implant date is between january 2007 and december 2012.Complainant part is not expected to be returned for manufacturer review/investigation.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.

Event Description

This report is being filed after the review of the following journal: urquhart jc, et al (2018), posterolateral versus posterior interbody fusion in lumbar degenerative spondylolisthesis, clin spine surg, volume 31, pages e446-e452 (canada).The purpose of this study is to evaluate the effectiveness of interbody fusion (if) compared with posterolateral fusion (plf) in terms of patient-rated satisfaction and functional outcome, as well as complication rate in a well-defined degenerative spondylolisthesis population.Between january 2007 and december 2012, 87 patients who underwent plf or posterior lumbar if for lumbar degenerative spondylolisthesis were included in the study.The mean age of patients at the time of assessment was 64.8 +/-9.4 years in which 50 of the patients were female.There were 29 patients in the plf group, and 58 patients were in the if group.During the procedure, the if was performed through a posterolateral or transforaminal approach using an interbody device which included the unknown synthes contact cage and 2 competitors¿ devices packed with autologous local bone graft collected during the decompression.For patients not receiving an interbody device, intertransverse process grafting was performed using both cancellous bone chip allograft and autologous local bone graft collected during the decompression.The authors did not specify which patients received the synthes cage.Thus, complications will be reported as follows: 1 patient had early subsidence of the cage which did not require intervention.3 patients had intraoperative dural tear/spinal fluid leak.3 patients had deep wound infection.3 patients had reoperation for irrigation and debridement.3 patients had revision surgery for adjacent level stenosis.5 patients had no radiographic fusion and had moderate back pain at 24 months after surgery.Unknown patients had leg pain at 24 months after surgery.Unknown patients had back pain at 24 months after surgery.2 patients died due to unrelated causes to the spinal surgery.A reported 2-y mortality rate of 3 patients.This report is for the unknown synthes contact cage.This report is for one (1) unknown contact fusion cage/spacers.This is report 2 of 2 for (b)(4).

• Brand Name: UNK - CAGE/SPACERS: CONTACT FUSION
• Type of Device: ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 11785388
• MDR Text Key: 264527196
• Report Number: 2939274-2021-02246
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2021
• 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: 04/12/2021
• 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