MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC; PLATE, FIXATION, BONE

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

Patient Problems Dysphagia/ Odynophagia (1815); Pain (1994); Weakness (2145); No Code Available (3191)

Event Date 03/15/2006

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown plates: spine-us/unknown lot number.Without the specific part number, the udi number and 510k 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 as no product was received.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, 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.Report was initially submitted on september 13, 2019 but the passed third acknowledgement was not received.Advised to resubmit medwatch november 04, 2019.The original submission was made within the 30 day reporting timeline.

Event Description

Device report from synthes reports an event in canada as follows: this report is being filed after the review of the following journal article:reindl r., et al, anterior reduction for cervical spine dislocation ,spine volume 31, number 6, pages 648¿652(canada)doi: 10.1097/01.Brs.0000202811.03476.A0.This retrospective study aims to evaluate patients with anterior stabilization for dislocation of the cervical spine.A total of 41 patients (29 male and 12 female) with disruptions of both anterior and posterior structures and subluxation or dislocacion of at least one facet were included in study.In all patients treated anteriorly, a tricortical bone graft from the anterior superior iliac crest was used.13 were treated with an anterior h-plate.The remainder were managed using the fixed angle anterior plate cslp ii or iii (synthes, paoli, pa).Clinical and radiologic evaluations with flexion-extension views were made at 6 weeks, 3 months, 6 months, 12 months, and 24 months.The mean follow-up period was 14.6 months (32 patients at 12 months and 9 patients at 24 months).The following complications were reported as follows: 2 patients required posterior surgery to achieve a reduction.5 patients showed evidence of radiologic instability at levels other than the dislocated/subluxed one.Upper extremity weakness was a common finding.These deficits markedly improved over the 12-month follow-up period.No improvement in frankel grade or upper extremity function was found in any of the 9 patients seen after 12 months.8 patients had dysphagia or odynophagia.A superficial wound infection occurred in 1 patient at the operative site in the neck.2 superficial infections occurred at the iliac crest donor site.1 patient deteriorated 1 frankel grade immediately after surgery with recovery to preoperative state at 12 months.5 patients had persistent neck pain, which was moderate to severe (6/10 on vas).1 patient required reoperation due to a missed injury above the origina fusion.One of the 2 patients requiring a posterior approach for reduction had a repeat anterior surgery for bone grafting and anterior plating to fill a significant anterior void created by a partial vertebrectomy.These impacted products capture the following adverse events: 2 patients required posterior surgery to achieve a reduction.Evidence of radiologic instability at levels other than the dislocated/subluxed one.Upper extremity weakness.No improvement in frankel grade or upper extremity function was found in any of the 9 patients seen after 12 months.Dysphagia or odynophagia.Persistent neck pain.2 patients requiring a posterior approach for reduction had a repeat anterior surgery for bone grafting and anterior plating to fill a significant anterior void created by a partial vertebrectomy.1 patient deteriorated 1 frankel grade immediately after surgery with recovery to preoperative state at 12 months.This report is for an unknown synthes fixed angle anterior plate cervical spine locking plate (cslp ii or iii) and unknown synthes screws.This report is for (1) unk - plates: spine.This report is 1 of 2 for (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.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).

• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9278270
• MDR Text Key: 166382501
• Report Number: 2939274-2019-61957
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 08/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2019
• 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: 11/07/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention