MAUDE Adverse Event Report: DEPUY SYNTHES SPINE SINGLE INNER POLYAXIAL SCREW 5.5 X 6.00 X 45MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Catalog Number 179712645

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

Patient Problems Internal Organ Perforation (1987); Injury (2348)

Event Type  Injury  

Manufacturer Narrative

Additional narrative: (b)(4).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.

Event Description

Rep left vm regarding expedium implants.Complaint form sent.On (b)(6) 2016: spoke with rep.During screw placement, pa plunged screw thru pedicle and caused internal damage to aorta.Vascular surgeon repaired damage and as of (b)(6) 2016, pt is ok and in icu.Patient had poor bone quality.No complaint against depuy spine products.Per complaint form: during removal and replacement of left l2 pedicle screw, surgeon plunged / advanced screw / screwdriver through pedicle and entered somewhere where vascular damage occurred.Case was aborted and vascular / cardiac / trauma surgeons entered the room.Patient was stabilized and taken to icu.There was no fault of our instrumentation / implants.They were involved in creating the issue but not the reason.

• Brand Name: SINGLE INNER POLYAXIAL SCREW 5.5 X 6.00 X 45MM
• 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: jason busch ; 325 paramount drive; raynham, MA 02767 ; 5088808201
• MDR Report Key: 5904721
• MDR Text Key: 53037001
• Report Number: 1526439-2016-10613
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: 179712645
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 08/01/2016
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other; Required Intervention