MAUDE Adverse Event Report: STRYKER SPINE-US 6.0X40 POLYAXIAL SCREW; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number	482616040
Health Effect - Clinical Codes	Injury (2348); No Known Impact Or Consequence To Patient (2692)
Date of Event	12/28/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the pedicle was broken post-operatively.The patient underwent revision surgery.Additional hardware were implanted during revision surgery.
Additional Manufacturer Narrative
Visual, dimensional, functional inspection, and material analysis could not be performed as the device remains implanted.Product and complaint history were reviewed and no relevant manufacturing issues nor similar events were identified.It was reported that an event with a screw resulted in damage to bone.A revision surgery occurred to extend the construct due to the fracture.The t8/9 yellow ligament was also removed.There were no complications during the initial surgery and no issues during screw insertion.It is unknown how the screw holes were prepared, patient¿s history, and bone quality.In addition, there was no patient fall.There is not enough information available to determine a root cause.Possible root causes that could have contributed to the event: improper screw hole prep, using the wrong sized screw, poor bone quality, under tapping, excessive patient post op activity, improper screw insertion.According to the ifu: "postoperative fracture of bone graft, the intervertebral body, pedicle, and/or sacrum above, and/or below the level of surgery, can occur due to trauma, the presence of defects, or poor bone stock.".
Event or Problem Description
It was reported that the pedicle was broken post-operatively.The patient underwent revision surgery.Additional hardware were implanted during revision surgery.

• Brand Name: 6.0X40 POLYAXIAL SCREW
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8420261
• Report Number: 3005525032-2019-00007
• Device Sequence Number: 13901895
• Product Code: NKB
• UDI-Device Identifier: 07613327351385
• UDI-Public: 07613327351385
• Combination Product (Y/N): N
• PMA/510(K) Number: K170496
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2019

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 482616040
• Device Lot Number: B83123OR B83123
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/18/2019
• Supplement Date Received by Manufacturer: 05/31/2019
• Initial Report FDA Received Date: 03/14/2019
• Supplement Report FDA Received Date: 06/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 43 YR