MAUDE Adverse Event Report: DEPUY SYNTHES SPINE BENGAL STACK LRG 20MM 0DEG MID; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Catalog Number 177300320

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Injury (2348)

Event Date 09/16/2015

Event Type  Injury  

Manufacturer Narrative

A complaint investigation will be performed.The complaint product is not available for the investigation.A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information.Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Sample not returned for evaluation.

Event Description

Procedure: acdf.Primary date: (b)(6) by dr (b)(6).Revision date: (b)(6) by dr (b)(6).No product fault just information.Exploration of anterior spine artery occlusion.Small clot was found and smaller cage reinserted.Product specialist was present during the procedure.Patient initials: (b)(6).Dob: (b)(6).Age: (b)(6).Gender: female.No x-rays, photographs, medical reports, clinical correspondence, operative notes or patient data/demographics are available.

Manufacturer Narrative

Incorrect on initial (mw-274325).Correct date is (b)(6) 2015.Device was not returned for evaluation.A trend analysis was conducted.No emerging trends were found requiring further actions.Without the returned of the device we are unable to confirm the reported issue or identify the root cause.As there has been no issue identified in the manufacturing or release of the device that could have contributed to the problem reported by the customer and no systemic trends were found, this complaint file will be closed with no further action required.Should more information and/or the sample be provided at a later time, this complaint will be reopened and device evaluated if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: BENGAL STACK LRG 20MM 0DEG MID
• Type of Device: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: michael jacene ; 325 paramount drive; raynham, MA 02767 ; 5089776485
• MDR Report Key: 5138294
• MDR Text Key: 27897893
• Report Number: 1526439-2015-10858
• Device Sequence Number: 1
• Product Code: MQP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK073649
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 09/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 177300320
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/08/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/03/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other
• Patient Age: 65 YR