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

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

Patient Problems Cerebrospinal Fluid Leakage (1772); Pain (1994); Non-union Bone Fracture (2369); Osteolysis (2377)

Event Type  Injury  

Event Description

This report is being filed after the review of the following journal article: balakumar b, et al (2021), a pragmatic single centre retrospective comparative review of complication profile between peek cages and zero-p cage screw constructs, british journal of neurosurgery, pages 1-8, (united kingdom).The primary aim of our study was to compare the zero-p cage with standalone cages for both single and multilevel surgery for any differences in the postoperative complications encountered in the short term.Between august 2016 to july 2018, 162 patients who underwent an anterior decompression and fusion were included in the study.There were 76 females and 89 males.The mean age at surgery was 52 years (18+/-84 years).There were 83 patients (111 cervical disc levels) who underwent fixation with standalone cage (sa) using a competitor¿s device.There were 79 patients (111 cervical disc levels) with who underwent cage-screw (cs) fixation using an unknown synthes zero-p cage.Bone graft substitute of unknown synthes dbx demineralized bone matrix or a competitor¿s bone graft substitute was used in all cases.Patients were allowed to mobilize the next day with the physical therapist.Most of the patients went home the next day.They were followed up in the clinic at 6 weeks, 6 months, and 1year.The mean follow-up was 9 months (2+/-28 months).Complications were reported as follows: ¿ 4 patients had transient swallowing problems.¿ 4 patients had hoarseness of voice.¿ 1 patient had cerebrospinal fluid leak.¿ 1 patient had adjacent segment disease.¿ 1 patient had recurrence of symptoms.¿ 12 patients had no fusion on the latest follow-up.¿ 17 patients had cage subsidence.¿ 28 patients required further interventions such as pain management, injections.This report is for the unknown synthes zero-p cage.This is report 2 of 2 for (b)(4).

Manufacturer Narrative

There are multiple patients.All known information is provided in the literature article.This report is for an unknown zero-p construct/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.

• Brand Name: UNK - CONSTRUCTS: ZERO-P
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH 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: 14653594
• MDR Text Key: 294870282
• Report Number: 8030965-2022-03884
• Device Sequence Number: 1
• Product Code: OVE
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2022
• 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: 05/13/2022
• 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