MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - CAGE/SPACERS: ALIF; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

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

Patient Problems Perforation of Vessels (2135); Non-union Bone Fracture (2369)

Event Date 04/30/2014

Event Type  Injury  

Manufacturer Narrative

Over the course of 2 1/2 years, the b.E.R.G.Approach was attempted in 202 patients scheduled for anterior interbody fusion at one or more levels.All but eight of them needed supplemental posterior fixation and/or fusion.Of these 202, 168 cases (83 male, 85 female) were completed successfully without conversion to an open procedure.Mean age in this group was 45 years, with a range of 23¿74 years.The date of event of april 30, 2014 is the date the literature article was published.510k: this report is for an unknown ao titanium interbody spacer (tis)/unknown lot.Part and lot number are unknown; udi number is unknown.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 article, 'thalgott j.S.Et al (2000) gasless endoscopic anterior lumbar interbody fusion utilizing the b.E.R.G.Approach, surgical endoscopy', volume 14, pages 546¿552(usa).This study aims to report that b.E.R.G.Approach offers significant technical advantages over the standard gas-mediated transperitoneal approach for alif.Over the course of 2 1/2 years, the b.E.R.G.Approach was attempted in 202 patients scheduled for anterior interbody fusion at one or more levels.All but eight of them needed supplemental posterior fixation and/or fusion.Of these 202, 168 cases (83 male, 85 female) were completed successfully without conversion to an open procedure.Mean age in this group was 45 years, with a range of 23¿74 years.All but eight patients were also instrumented posteriorly, 128 with translaminar fixation and 32 with transpedicular fixation, with or without posterolateral fusion.The surgical team has several options for fusion¿anatomic cage, screw-in cage, allograft, or autograft with the following devices: (89) femoral ring allograft/coralline hydroxyapatite; (37) ao titanium interbody spacer (tis)/coralline hydroxyapatite core; (21) ao syn cage/iliac crest autograft; (12) femoral ring allograft/local autograft; (6) bak/iliac crest autograft; (2) ray cage/iliac crest autograft; (1) harms (moss) cage/iliac crest autograft.The first 50 patients in this series have a minimum follow-up of 24 months and a maximum of 36 months.This report captures the following adverse events: perioperatively, six vessel lacerations were repaired endoscopically without sequelae.There was also one ruptured diverticulum.Of the 142 patients undergoing either anteroposterior surgery on the same day or stand-alone alif, one retrograde ejaculation and one deep vein thrombosis (dvt) in this series as well as two postoperative foot drops, which were secondary to the posterior procedures were encountered.Two patients had their posterior hardware removed.One was solidly fused, the other had a pseudarthrosis and was redone posteriorly.Only 46 of 50 patients (92%) were solidly fused at 24 months.This report is for an unknown ao titanium interbody spacer (tis).This is report 1 of 9 for (b)(4).Additional devices are captured on related complaint (b)(4).A copy of the literature article is being submitted with this medwatch.

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.H10 additional narrative: investigation summary = 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.

• Brand Name: UNK - CAGE/SPACERS: ALIF
• Type of Device: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• 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: 10811999
• MDR Text Key: 215490626
• Report Number: 2939274-2020-05030
• Device Sequence Number: 1
• Product Code: MQP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 10/14/2020
• Initial Date FDA Received: 11/09/2020
• Supplement Dates Manufacturer Received: 07/14/2022
• Supplement Dates FDA Received: 08/04/2022
• 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