MAUDE Adverse Event Report: SYNTHES GMBH UNK - PLATES: VECTRA-T PLATE; PLATE, FIXATION, BONE

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Dysphagia/ Odynophagia (1815); Nerve Damage (1979); Post Operative Wound Infection (2446)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Additional narrative: 510k: this report is for an unk - plates: vectra-t plate/unknown lot.Part and lot numbers 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 as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.The product was not returned.Based on the information available, it has been determined that no corrective and 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

Device report from synthes reports an event in (b)(6) as follows: the current report is a retrospective analysis of 33 patients (19 female and 14 males) who underwent instrumentation with vectra-t between january 02, 2006, and november 22, 2020.19 patients had additional interbody device of non-depuy brand.Mean age of the patients was 53 years.Registered intra-operative complications: 1 medullary injury.Registered post-op complications within 1 year: 9 dysphagia.6 recurrent nerve injury.3 ssi superficial.Global assessment of neck pain : failure % : fu 1 yrs.32%, fu 2 yrs.38% , fu 5 yrs.79%.Global assessment of arm pain (ga) : failure % : fu 1 yrs.30%, fu 2 yrs.32% , fu 5 yrs.29%.This is for vectra-t.This report is for one (1) unk - plates: vectra-t plate this is report 4 of 4 for complaint (b)(4).

Event Description

This report is being filed after the review of a clinical evaluation report (cer) from a related research activity database (ddra) for a total of 195 patients (51% were female) have been operated with the vectra-t implant between (b)(6) 2006 and (b)(6) 2022.188 cases are combined with non-depuy devices, 5 have missing data on secondary anterior implant and 2 have misregistration of secondary implant.This report analyzes 195 implants.The following complications reported from swedish spine registry (swespine) database were: intra-operative complications (n=2): n=1 had medullary injury.N=1 had other complications.Post-op complications within 1 year (n=88): n=50 had dysphagia.N=33 had vocal cord dysfunction.N=5 had infection.

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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.

• Brand Name: UNK - PLATES: VECTRA-T PLATE
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12703736
• MDR Text Key: 278566972
• Report Number: 8030965-2021-09033
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2021
• 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: 02/17/2023
• 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