MAUDE Adverse Event Report: DEPUY SYNTHES SPINE 5.5 TI POLYAXIAL WIDE LAG SCREW 8X80MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Catalog Number 179704880

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

Patient Problem Death (1802)

Event Date 03/09/2016

Event Type  Death  

Manufacturer Narrative

(b)(4).Complaint will be reported as adverse event.The cause of death is unknown but the reported screws should not be directly related.The samples will not be returned because it was left in the patient¿s body.There is no indication that the depuy spine devices caused or contributed to the event.No reported malfunction or failure in the instruments and implants.All patient deaths reported to depuy spine in which depuy spine device(s) have been or were being implanted will be reported as mdr events regardless of causality.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

On (b)(6) 2016, an xlif was initially performed on a patient with degenerative lumbar kyphoscoliosis.It was successfully completed.On (b)(6) 2016, a posterior spinal fusion was performed with the reported screws.After decompression and fusion for t10-sai was completed, the patient became cardiac arrest.On the following day at 6:30pm, it was informed that the patient died.The cause of death is unknown but the reported screws should not be directly related.The samples will not be returned because it was left in the patient¿s body.

• Brand Name: 5.5 TI POLYAXIAL WIDE LAG SCREW 8X80MM
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• Manufacturer Contact: michael jacene ; 325 paramount drive; raynham, MA 02767 ; 5089776485
• MDR Report Key: 5548346
• MDR Text Key: 41907667
• Report Number: 1526439-2016-10256
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK111571
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 179704880
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 03/10/2016
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death