MAUDE Adverse Event Report: SYNTHES GMBH SYNEX(TM) WITH SMALL ENDPLATE -5 DEG/28MM-40MM HEIGHT; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Catalog Number 495.318

Device Problems Migration or Expulsion of Device (1395); Patient Device Interaction Problem (4001)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

Additional narrative: 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.Product was not returned.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 (b)(6) reports an event as follows: it was reported that on (b)(6) 2021 the primary l2 centrum replacement and spinal fusion was performed.On an unknown date, it was found that the cage (deployed at l1) had sunk and tilted.On (b)(6) 2021 the patient went a revision procedure where the cage was replaced with a non-synthes cage.This report is for a cage.This is report 1 of 1 for (b)(4).

• Brand Name: SYNEX(TM) WITH SMALL ENDPLATE -5 DEG/28MM-40MM HEIGHT
• Type of Device: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK HÄGENDORF (CH); im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12326644
• MDR Text Key: 266739012
• Report Number: 8030965-2021-06702
• Device Sequence Number: 1
• Product Code: MQP
• UDI-Device Identifier: 07611819109025
• UDI-Public: (01)07611819109025
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K003836
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 495.318
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/19/2021
• 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