MAUDE Adverse Event Report: SYNTHES GMBH VECTRA-T-PL 4/4.5 4 SEGMENTS L69 TAN; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Catalog Number 450.581S

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

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.H10 additional narrative: d9: complainant part is not expected to be returned for manufacturer review/investigation.E1: (b)(6).E3: reporter is a j&j employee.H4, h6:: part # 450.581s.Lot # l482336.Manufacturing site: werk selzach.Release to warehouse date: 28 jun 2017.Expiration date: 01 jun 2027.Supplier: (b)(4).A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Non-sterile part # 450.581.Non-sterile lot # l476613.Manufacturing site: werk mezzovico.Release to warehouse date: 21 jun 2017.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 japan as follows: it was reported that this was an anterior cervical fusion for opll on (b)(6) 2023.The surgery was completed successfully with no surgical delay.After surgery, there were signs of infection.A ct scan showed something like a wire near the implant.A contrast examination revealed leakage of contrast agent from the esophagus, and a diagnosis of retropharyngeal abscess was made.When the images taken immediately after the surgery were checked again, and a protrusion was confirmed.Antibiotics were used to try to calm down the infection, but the infection was not sedated sufficiently, so a reoperation was performed and a debridement was done.Upon direct visual inspection, a silver wire-like protrusion was confirmed.The silver wire-like protrusion appeared to have been scraped off by interference with the washer part of the plate when the screw was inserted.Only the protruding part was removed with a luer, and the implant itself was not removed.The reoperation was completed successfully with no surgical delay.The surgeon commented as follows: it appears that the screw interfered with the washer part of the plate when it was inserted and was scraped.It is assumed that the scraped part interfered with the esophagus and perforated it, causing the infection to spread.In the past, there was a case where it felt like the washer and screw were interfering with each other, but in that case, the protruding part was removed during the surgery.No further information is available.This report is for one (1) vectra-t-pl 4/4.5 4 segments l69 tan.This is report 9 of 9 for complaint (b)(4).

Event Description

The implants were not explanted.Patient was treated with debridement, but symptoms are unknown.

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.

• Brand Name: VECTRA-T-PL 4/4.5 4 SEGMENTS L69 TAN
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 17950236
• MDR Text Key: 325857180
• Report Number: 8030965-2023-13040
• Device Sequence Number: 1
• Product Code: KWQ
• UDI-Device Identifier: 07611819952706
• UDI-Public: (01)07611819952706
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K051665
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 450.581S
• Device Lot Number: L482336
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: CERVIC-SPINE-SCR ø4 DYNAM SELF-DRILL L14; CERVIC-SPINE-SCR ø4 DYNAM SELF-DRILL L14; CERVIC-SPINE-SCR ø4 DYNAM SELF-DRILL L18; CERVIC-SPINE-SCR ø4 DYNAM SELF-DRILL L18; CERVIC-SPINE-SCR ø4 DYNAM SELF-DRILL L18; CERVIC-SPINE-SCR ø4 DYNAM SELF-DRILL L18; CERVIC-SPINE-SCR ø4 DYNAM SELF-DRILL L18; CERVIC-SPINE-SCR ø4 DYNAM SELF-DRILL L18
• Patient Outcome(s): Required Intervention