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

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

Patient Problem Neck Pain (2433)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown biomaterial - cement: vertecem v+/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.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) for evaluating surgical outcomes of depuy synthes spine fenestrated screws (viper and expedium) with or without the use of spinal cement (confidence or vertecem v+cement)in adult spinal deformity (asd) surgery.From all the surgical asd patients included in the essg database (july 2020), 500 were treated specifically with depuy synthes spine screws.(410 patients) of them were female and (90 patients) were male.From them, 34 patients (30 females,4 males) age 68.1 (sd 10.6) were treated with fenestrated screws with or without spinal cement (confidence or vertecem v+ cement):28 with spinal cement and 6 without spinal cement.Type of complications in patients with dps fenestrated screws.Medical : 7 urinary tract infection (minor), 1 bacteremia (minor), 1 sepsis (major), 1 renal failure (major), 1 delirium (minor), 1 re-intubation after extubation (major), 1 pleural effusion (minor), 1 reflex sympathetic dystrophy (major), 1 coagulopathy (minor), 2 anemia (minor), 2 electrolyte imbalance (minor).Intraoperative : 1 abnormal bleeding (ml) (>4l) (minor), 4 dural tear (1 major,3 minor), 1 cement leak (minor).Wound problems: 2 wound dehiscence (2 major), 5 superficial wound infection (2 major, 3 minor), 3 deep wound infection (major).Mechanical: 10 pseudarthrosis (9 major,1 minor), 9 proximal junctional kyphosis (6 major ,3 minor), 5 proximal junctional failure (4 major,1 minor), 1 adjacent segment degeneration (major), 1 distal junctional kyphosis (major), 1 loss of correction (major), 1 vertebral fracture (major), 1 pedicle fracture (major).Neurologic: 1 epidural hematoma (major), 5 radiculopathy (4 major,1 minor), 1 pain (minor).This is for depuy synthes vertecem v+cement.This is report 6 of 6 for (b)(4).This product complaint, (b)(4), is related to (b)(4).

• Brand Name: UNK - BIOMATERIAL - CEMENT: VERTECEM V+
• 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: 11776541
• MDR Text Key: 249022208
• Report Number: 8030965-2021-03571
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 04/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2021
• 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: 04/07/2021
• 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