MAUDE Adverse Event Report: SYNTHES GMBH UNK - CAGE/SPACERS/BIO: CERVIOS CHRONOS; INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION,LUMBAR

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

Patient Problems Dysphagia/ Odynophagia (1815); Hematoma (1884); Post Operative Wound Infection (2446); Embolism/Embolus (4438)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Depuy this report is for an unk - cage/spacers/bio: cervios chronos/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/ investigation.Initial reporter is a j&j representative.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 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 denmark as follows: this report is being filed after the review of a clinical evaluation report (cer) from a related research activity database (ddra) for patients undergoing acdf.The purpose of this study is to evaluate performance and safety of the cervios cage in patients undergoing acdf for degenerative conditions of the cervical spine in a period from september 2011 until february 2017.Patients were at least 18 years of age with a minimum of 12-month post-operative data available.The following complications: intraoperative complications: 7 patients had dural tear.Immediate post-op complications: 1 patient had emboli.2 patients had hematoma.1 patient had dvt.90-day complications: 1 patient had deep vein thrombosis.2 patients had pulmonary embolism.10 patients had superficial infection.4 patients had deep infection.14 patients had new neurologic deficit.53 patients had hoarseness (patient reported).68 patients had dysphagia (patient reported).Reoperations due to: case 1: repeat decompression.Case 2: repair of csf leak.Case 3: evacuation of hematoma.Case 4: evacuation of hematoma.Case 5: evacuation of hematoma.Case 6: evacuation of hematoma.Case 7: evacuation of hematoma.This report is for an unknown synthes cervios.This report is for (1) unk - cage/spacers/bio: cervios chronos this report is 2 of 9 for (b)(4).

• Brand Name: UNK - CAGE/SPACERS/BIO: CERVIOS CHRONOS
• Type of Device: INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION,LUMBAR
• 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: 12591727
• MDR Text Key: 278111333
• Report Number: 8030965-2021-08478
• Device Sequence Number: 1
• Product Code: OVD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2021
• 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: 09/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention