MAUDE Adverse Event Report: STRYKER SPINE-US OASYS 3.5 X 26MM PA SCREW SMOOTH SHANK; POSTERIOR CERVICAL SCREW SYSTEM

Model Number 48556326

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/12/2023

Event Type  Injury  

Event Description

It was reported that 4 days post-operatively the head of an oasys smooth shank polyaxial screw had separated from the shank.The screw was removed during a revision surgery which lasted 3 hours.

Manufacturer Narrative

Corrected data: d6a, d6b.Additional data: d4 , h4.

Event Description

It was reported that 4 days post-operatively the head of an oasys smooth shank polyaxial screw had separated from the shank.The screw was removed during a revision surgery which lasted 3 hours.

• Brand Name: OASYS 3.5 X 26MM PA SCREW SMOOTH SHANK
• Type of Device: POSTERIOR CERVICAL SCREW SYSTEM
• 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: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 16968677
• MDR Text Key: 315672448
• Report Number: 0009617544-2023-00030
• Device Sequence Number: 1
• Product Code: NKG
• UDI-Device Identifier: 07613327067606
• UDI-Public: 07613327067606
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K151755
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 48556326
• Device Catalogue Number: 48556326
• Device Lot Number: 059898
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2006
• 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): Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male