MAUDE Adverse Event Report: SYNTHES GMBH UNK - BIOMATERIAL - CEMENT: VERTECEM; POLYMETHYLMETHACRYLATE BONE CEMENT

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

Patient Problems Osteolysis (2377); Neck Pain (2433); Post Operative Wound Infection (2446); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown biomaterial - cement: vertecem/ unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/ investigation.Reporter is a synthes employee.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.(b)(4).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: this report is being filed after the review of a clinical evaluation report (cer) from a related research activity database (ddra) to compare usage and outcomes recorded in 74 patients (28 males, 46 females) for viper / expedium pedicle screws with vertecem+ against all other surgical cases recorded within the spine tango registry between 06 february 2013 and 29 august 2018.Final registry report outcome description: general complications-intraoperative: 1 anaesthesiological, 1 pulmonary.Surgical complications- intraoperative adverse events: 3 dural lesion.General complications- postoperative surgical before discharge: 4 cardiovascular, 2 pulmonary, 1 cerebral, 3 kidney / urinary, 1 liver / gi, 1 thromboembolism, 2 other, 2 not documented, 1 death.Surgical complications- postoperative surgical before discharge: 1 other hematoma, 1 radiculopathy, 2 motor dysfunction, 2 sensory dysfunction, 1 bowel / bladder dysfunction, 1 wound infection superficial, 10 wound infection deep, 1 implant failure, 2 other, 2 not documented.Reoperations : 4 number of reoperations at any level: 2 adjacent segment pathology, 2 failure to reach therapeutic goals, 1 hardware removal, 1 implant failure, 1 instability, 1 neurocompression, 1 sagittal imbalance, 1 unknown, 1 number of reoperations at the same level, 1 unknown.This is for unknown biomaterial - cement: vertecem.This is report 2 of 2 for (b)(4).

• Brand Name: UNK - BIOMATERIAL - CEMENT: VERTECEM
• Type of Device: POLYMETHYLMETHACRYLATE BONE CEMENT
• 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: 12436039
• MDR Text Key: 270543639
• Report Number: 8030965-2021-07553
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/24/2021
• 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