MAUDE Adverse Event Report: XENCO MEDICAL LLC XENCO MEDICAL CERVICAL INTERBODY SYSTEM; INTERVERTEBRAL BODY FUSION DEVICE

Catalog Number XM-216-4012

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Patient-Device Incompatibility (2682)

Patient Problem Spinal Column Injury (2081)

Event Date 07/13/2017

Event Type  Injury  

Manufacturer Narrative

Lot history records reviewed for lot numbers 3571705, 4876978 with no nonconformities noted for either lot.Product ifu and surgical technique were reviewed and no discrepancies found in either document.Osteoporosis is listed as a relative contraindication within the ifu (xm-116-1300-75, rev b) and surgical technique (xm-mkt-16-011, rev b) within the following statement, "rapid joint disease, bone absorption, osteopenia; osteoporosis (relative contraindication) - may limit the degree of obtainable correction, stabilization, and/or the amount of mechanical fixation." patient bone was noted as osteoporotic and may have contributed to decrease in bone purchase and screw back out.The event is being reported after 30 days due to issues setting up webtrader account.

Event Description

During patient follow up visit, discovered plate screws backed out at level c4-c5.Subsequent revision surgery performed and replaced with competitor implant.

• Brand Name: XENCO MEDICAL CERVICAL INTERBODY SYSTEM
• Type of Device: INTERVERTEBRAL BODY FUSION DEVICE
• Manufacturer (Section D): XENCO MEDICAL LLC; 9930 mesa rim road; san diego CA 92121
• Manufacturer Contact: michelle willis ; 9930 mesa rim road; san diego, CA 92121
• MDR Report Key: 6872340
• MDR Text Key: 86468178
• Report Number: 3011181154-2017-00001
• Device Sequence Number: 1
• Product Code: ODP
• UDI-Device Identifier: B084XM21640122
• UDI-Public: +B084XM21640122
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160313
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 12/15/2019
• Device Catalogue Number: XM-216-4012
• Device Lot Number: 3571705
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 86 YR