MAUDE Adverse Event Report: SYNTHES GMBH VERTEBRAL BODY SET/SMALL- STERILE; ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION

Catalog Number 09.804.600S

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

Patient Problems Physical Asymmetry (4573); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/27/2021

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).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 patient underwent a kyphoplastie procedure at l4 due to osteoporotic sintering fracture.The desired reduction could not be achieved with the vertebral body set.The procedure was completed using cement application with jamshidi needle.There was a surgical delay of five to ten (5-10) minutes.The procedure was completed without the desired reposition.This report is for one (1) vertebral body set/small- sterile.This is report 1 of 2 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.H3, h4, h6: part # 09.804.600s, synthes lot # j002434, supplier lot # 82213553, release to warehouse date: 15feb2021, expiration date: 01feb2024, supplier: (b)(4).A non-conformance was generated and is not relevant to the adverse impact in the product.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 SET/SMALL- STERILE
• Type of Device: ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12459957
• MDR Text Key: 271028302
• Report Number: 8030965-2021-07658
• Device Sequence Number: 1
• Product Code: MNH
• 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: 08/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2024
• Device Catalogue Number: 09.804.600S
• Device Lot Number: J002434
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/23/2021
• Patient Sequence Number: 1
• Treatment: VBS W/BALLOON SM; VBS W/BALLOON SM
• Patient Outcome(s): Required Intervention
• Patient Age: 88 YR
• Patient Weight: 80