MAUDE Adverse Event Report: STRYKER SPINE-US 16MM 1 LEVEL PLATE 2-SCREW; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Catalog Number	49173116
Medical Device Problem Codes	Difficult to Insert (1316); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that one of the locking covers on a lite 2-screw plate was jamming intra-operatively.The procedure was completed successfully using a replacement plate with a three minute surgical delay and no adverse consequence to the patient.
Additional Manufacturer Narrative
Additional data: h3 h6 coding has been updated to reflect completion of the investigation.
Event or Problem Description
No new information.

• Brand Name: 16MM 1 LEVEL PLATE 2-SCREW
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• Manufacturer (Section G): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer Contact: matthew kelleher ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 21635982
• Report Number: 0009617544-2025-00023
• Device Sequence Number: 9276813
• Product Code: KWQ
• UDI-Device Identifier: 07613327066449
• UDI-Public: (01)07613327066449(11)190110(10)190192
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K150449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 49173116
• Device Lot Number: 190192
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/16/2025
• Supplement Date Received by Manufacturer: 05/30/2025
• Initial Report FDA Received Date: 03/18/2025
• Supplement Report FDA Received Date: 06/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown