MAUDE Adverse Event Report: SYNTHES GMBH VERTEBRAL BODY STENT-LARGE; POLYMETHYLMETHACRYLATE BONE CEMENT

Catalog Number 09.804.502S

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/04/2020

Event Type  Injury  

Manufacturer Narrative

Device is not distributed in the united states, but is similar to device marketed in the usa.Manufacturing location: supplier - confluent / inspected and released by: (b)(4).Release date: june 26, 2020.Expiration date: may 01, 2023.Part: 09.804.502s, vertrebal body stent-large.Lot : h89023 (sterile).Purchased finished goods traveler met all inspection acceptance criteria.Certificate of conformance supplied by confluent was reviewed and determined to be conforming.Inspection sheet, incoming final inspection met all inspection acceptance criteria.Packaging was reviewed per inspection sheet requirements and determined to be conforming.This lot met all visual, sterility and packaging criteria at the time of release with no issues documented during the inspection or release of the product that would contribute to this complaint condition.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 (b)(6) reports an event as follows: it was reported that during a procedure on (b)(6) 2020, the surgeon inserted both stents into the vertebral body and after x-ray control wanted to retract the stent slightly.Unfortunately, the stent remained in place and the surgeon retracted only the balloon.The surgeon then inserted a new stent, which he inflated successfully.Procedure was completed successfully with a delay of ten (10) minutes.There was no patient consequence.This report is for a vertebral body stent-large.This is report 1 of 1 for (b)(4).

• Brand Name: VERTEBRAL BODY STENT-LARGE
• Type of Device: POLYMETHYLMETHACRYLATE BONE CEMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 11140736
• MDR Text Key: 229600531
• Report Number: 8030965-2021-00172
• Device Sequence Number: 1
• Product Code: NDN
• UDI-Device Identifier: 07611819432628
• UDI-Public: (01)07611819432628
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 12/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2023
• Device Catalogue Number: 09.804.502S
• Device Lot Number: H890231
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/26/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR