MAUDE Adverse Event Report: STRYKER GMBH G4 LAG SCREW D10,5XL90; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 81600090S

Device Problems Device Dislodged or Dislocated (2923); Migration (4003)

Patient Problem Perforation (2001)

Event Date 12/09/2023

Event Type  Injury  

Event Description

As reported: "gamma4 nail to fix an intertroch fx.4-6 week post op xrays looked normal, as expected.Pt then presented to ed 12/9, -xrays showed lag screw completely disengaged and medialized.Patient needed revision surgery.

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

• Brand Name: G4 LAG SCREW D10,5XL90
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18426895
• MDR Text Key: 331781452
• Report Number: 0009610622-2024-00007
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07613327510928
• UDI-Public: 07613327510928
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K213328
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 81600090S
• Device Lot Number: K158B35
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2023
• Was Device Evaluated by Manufacturer?: No
• 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: 89 YR
• Patient Sex: Female