MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: ZERO-P VA; INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, CERVICAL

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Ossification (1428); Dysphagia/ Odynophagia (1815); Failure of Implant (1924); Osteolysis (2377)

Event Date 09/13/2021

Event Type  Injury  

Event Description

This report is being filed after the review of the following journal article: yao x, et al.(2021), treatment of cervical spondylotic myelopathy with variable angle zero-profile anterior fusion and internal fixation system: a 30-month follow-up, chinese journal of tissue engineering research, 2022,26 (9): 1377-1382, (china).The objective of the study was to evaluate the mid-term outcome of cervical spondylotic myelopathy treated with variable-angle zero-notch anterior interbody fusion system.From january 2015 to january 2018, 81 patients with cervical spondylotic myelopathy who underwent surgical treatment were included in the study.Among them, 42 patients received anterior cervical discectomy and decompression and fusion using variable-angle zero-notch anterior interbody fusion system (study group); 39 patients received anterior cervical discectomy and decompression and fusion using traditional titanium plate-cage system (control group).In the study group, there were 28 males and 14 females with a mean age of 55.81 ± 10.22 years.Patients in the study group were implanted with an unknown synthes variable angle zero-profile anterior fusion system.In the control group, there were 20 males and 19 females with a mean age of 55.59 ± 13.18 years.The patients in the control group were implanted with a competitor¿s titanium plate-cage system.Postoperatively, the neck collar could be worn for off-bed activity 3 days after operation.The patient could be discharged about 1 week after operation.The neck collar was worn for protection for 6-8 weeks after discharge.The neck functional exercise was started after removing the neck collar.The mean follow-up time in the study group was 33.45 ± 4.28 months postoperative and the mean follow-up time in the control group was 31.90 ± 4.72 months postoperative.The complications were reported as follows: (study group): 10 patients had cage subsidence.9 cases of cage subsidence had complete fusion and 1 case had partial fusion.In the partial fusion case, the cage subsidence was found in the computed tomography at 1 month after operation.It was considered that the middle endplate injury was related.1 patient has postoperative mild dysphagia.The patient had no obvious symptoms during follow-up.4 patients had postoperative adjacent vertebral body ossification.1 patient had significant degeneration of adjacent intervertebral disc at 30 months after the operation.This report is for unk - constructs: zero-p va.This is report 1 of 1 for (b)(4).

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.This report is for an unknown device/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.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.

• Brand Name: UNK - CONSTRUCTS: ZERO-P VA
• Type of Device: INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, CERVICAL
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15182939
• MDR Text Key: 297427682
• Report Number: 8030965-2022-05628
• Device Sequence Number: 1
• Product Code: OVE
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2022
• 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: 07/12/2022
• 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): Other