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

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/13/2013

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).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.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 for investigation.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 (b)(6) as follows: this report is being filed after the review of the following journal article: müller, f.And füchtmeier, b.(2013), percutaneous cement-augmented screw fixation of bilateral osteoporotic sacral fracture, der unfallchirurg, vol.116 (xx), pages 950¿954 (b)(6).This study presents a case report of a (b)(6) year-old female patient who had an osteoporotic bilateral sacral fracture.Surgery was performed using cement, vertecem v, synthes, (b)(6).The postoperative x-ray control including ct of the pelvis showed a normal screw position with normal cement distribution in the sacrum.Only on the right lateral side, in the area of the cannulated screw head, was there a small asymptomatic cement leak (fig.4).This report is for an unknown synthes vertecem v+ cement.A copy of the literature article is being submitted with this medwatch.This report is for (1) unk - biomaterial - cement: vertecem v.This report is 1 of 1 (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 ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 11842882
• MDR Text Key: 251227105
• Report Number: 8030965-2021-04015
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 71 YR