MAUDE Adverse Event Report: STRYKER SPINE-US 7.5X35 POLYAXIAL SCREW; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	482617535
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Hospital retained device.
Event or Problem Description
A physician reported a fractured xia serrato polyaxial screw at s1 in a two-level construct.The device has been explanted.
Additional Manufacturer Narrative
Visual, dimensional, functional and material analysis could not be performed as the device was not returned.Device and complaint history records were reviewed for this lot, and no relevant manufacturing issues or similar complaints were identified.  per follow up, there were no complications during initial surgery, patient did not fuse.Due to a lack of information and the device not being returned, the root cause of the reported event can not be determined.Potential causes include: high activity level of patient, poor bone quality of patient, overtightened construct, inadequate screw hole preparation during initial surgery.
Event or Problem Description
A physician reported a fractured xia serrato polyaxial screw at s1 in a two-level construct.The device has been explanted.

• Brand Name: 7.5X35 POLYAXIAL SCREW
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 11564082
• Report Number: 3005525032-2021-00011
• Device Sequence Number: 4881693
• Product Code: NKB
• UDI-Device Identifier: 07613327352542
• UDI-Public: 07613327352542
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K170496
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2021

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: 482617535
• Device Catalogue Number: 482617535
• Device Lot Number: B97195
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/24/2021
• Supplement Date Received by Manufacturer: 05/31/2021
• Initial Report FDA Received Date: 03/24/2021
• Supplement Report FDA Received Date: 06/30/2021
• 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