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

Catalog Number 09.804.501S

Device Problem Mechanical Problem (1384)

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

Event Date 07/01/2021

Event Type  malfunction  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.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: it was reported that on (b)(6) 2021, the customer reported that the vertebral body stent did not open completely or the basket came off.It is unknown if there was surgical or patient involvement.There is no further information available.This report is for one (1) vertebral body stent-medium.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: g4: device is not distributed in the united states, but is similar to device marketed in the usa.H3, h4, h6: part 09.804.501s, synthes lot h890230, supplier lot 82196179: release to warehouse date: july 01, 2020.Expiration date: july 01, 2023.Supplier: (b)(4).There is no non-conformance reports (ncr) associated to the requested lot.H3, h6: a photo investigation was completed: the vbs medium stent was not returned.A photo-investigation was performed on the provided images.Upon inspecting the images provided, its noticed that the stent does not completely open or the stent basket separates from the stem before opening completely.The reported complaint condition could be confirmed on the received pictures.Product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.During the investigation, no product design issues, or discrepancies were observed.No manufacturing issues were noted during investigation.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.

• Brand Name: VERTEBRAL BODY STENT-MEDIUM
• Type of Device: POLYMETHYLMETHACRYLATE BONE CEMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12181157
• MDR Text Key: 261978704
• Report Number: 8030965-2021-05824
• Device Sequence Number: 1
• Product Code: NDN
• UDI-Device Identifier: 07611819432611
• UDI-Public: (01)07611819432611
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2023
• Device Catalogue Number: 09.804.501S
• Device Lot Number: H890230
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/27/2021
• Patient Sequence Number: 1