MAUDE Adverse Event Report: STRYKER SPINE-US 7.5X80 MEDIAL BIASED ANGLE POLYAXIAL SCREW; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	482677580
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/06/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is anticipated to be returned.
Event or Problem Description
It was reported that a serrato polyaxial screw tulip disengaged post-operatively.The tulip disengagement was discovered during a revision surgery that was being performed for a suspected infection.It is unknown what caused the infection.
Additional Manufacturer Narrative
Visual, dimensional, material and functional analysis could not be performed as the device was not returned.A review of the device and complaint history records could not be performed as a valid lot code was not provided and could not be obtained.From the xia instructions for use: transient bacteremia can occur in daily life.Dental manipulation, endoscopic examination and other minor surgical procedures have been associated with transient bacteremia.To help prevent infection at the implant site, it is advisable to use antibiotic prophylaxis before and after such procedures.Pre-cleaning / cleaning and sterilization procedure recommended for non sterile medical devices: for safety reasons, non-sterile devices must be pre-cleaned, cleaned and sterilized prior to use.Moreover, for good maintenance, reusable instruments must be pre-cleaned, cleaned and sterilized immediately after surgery following the sequence of steps described in the following chart.It is unknown if the screw caused or contributed to the infection.Breach of sterile barrier and/or improper sterilization of instruments/implants can introduce pathogens into the wound site and cause an infection.There is not enough information provided to determine the root cause of the infection.Additionally, based on the information provided, a root cause for the tulip disengagement cannot be determined.Possible root causes from the risk file include excessive patient post op activity, patient fall, poor construct design, and/or excessive torque applied during final tightening.
Event or Problem Description
It was reported that a serrato polyaxial screw tulip disengaged post-operatively.The tulip disengagement was discovered during a revision surgery that was being performed for a suspected infection.It is unknown what caused the infection.

• Brand Name: 7.5X80 MEDIAL BIASED ANGLE POLYAXIAL SCREW
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 9925191
• Report Number: 3005525032-2020-00023
• Device Sequence Number: 19651304
• Product Code: NKB
• UDI-Device Identifier: 07613327351699
• UDI-Public: 07613327351699
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2020

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
• Operator of Device: Health Professional
• Device Model Number: 482677580
• Device Catalogue Number: 482677580
• Device Lot Number: B77¿
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/06/2020
• Supplement Date Received by Manufacturer: 05/30/2020
• Initial Report FDA Received Date: 04/03/2020
• Supplement Report FDA Received Date: 06/26/2020
• 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: Other