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 Post Operative Wound Infection (2446)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Additional narrative: 510k: this report is for an unk - 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 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, no further action is required at this time.Complaint information is trended on a regular basis to determine if further investigation is warranted.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 switzerland as follows: this report is being filed after the review of a clinical evaluation report (cer) from a database related research activity (drra) patient who underwent depuy synthes uss pedicle screws used with vertecem+.The following complications have been identified as per the spine tango report: interop adverse events 2 - dural lesion.Postoperative general complications: 2 - pulmonary.3 - cerebral.3 - liver/gi.1 - other.Postop surgical before discharge: 2 - motor dysfunction.1 - wound infection superficial.1 - wound infection deep.Reoperation: 1 - instability.This report is for a depuy synthes uss pedicle screws used with vertecem+.This report is for (1) unk - biomaterial - cement: vertecem v+.This report is 4 of 4 for (b)(4).

Event Description

This report is being filed after the review of a clinical evaluation report (cer) from a database related research activity (drra) patients who underwent depuy synthes uss pedicle screws used with vertecem+.The following complications have been identified as per the spine tango report: intraop adverse events: 2 - dural lesion.Postoperative general complications: 2 - pulmonary.3 - cerebral.3 - liver/gi.1 - other.Postop surgical before discharge: 2 - motor dysfunction.1 - wound infection superficial.1 - wound infection deep.Reoperation before discharge: 1 - instability.Complications at follow-up: 1- sensory dysfunction.4- implant failure.2- csf leak/ pseudomeningocele.1- wound infection superficial.1- wound infection deep.1- recurrence of symptoms.1- graft complication.1- fracture vertebral structures.1- other.Reoperation at follow-up: 2-hardware removal.1-postoperative infection.2-other.This report is for a depuy synthes uss pedicle screws used with vertecem+.A copy of the clinical evaluation form is being submitted with this regulatory report.

• 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: 12509547
• MDR Text Key: 272685377
• Report Number: 8030965-2021-07911
• 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: Foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2021
• 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: 01/12/2024
• 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