MAUDE Adverse Event Report: STRYKER SPINE-US AVS PL INSERTER 8 AND 9MM; PL INSERTER 8-9 STRAIGHT

Model Number 48350951

Device Problems Deformation Due to Compressive Stress (2889); Material Deformation (2976)

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

Event Date 06/01/2022

Event Type  malfunction  

Event Description

A company representative reported that an avs pl inserter bent at the distal tip and middle during intra-operative implant placement.There were no adverse consequences to the patient.The procedure was completed successfully without surgical delay.

Manufacturer Narrative

H6 coding has been updated to reflect device evaluation and investigation conclusion.

Event Description

A company representative reported that an avs pl inserter bent at the distal tip and middle during intra-operative implant placement.There were no adverse consequences to the patient.The procedure was completed successfully without surgical delay.

• Brand Name: AVS PL INSERTER 8 AND 9MM
• Type of Device: PL INSERTER 8-9 STRAIGHT
• 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: 14875781
• MDR Text Key: 300917256
• Report Number: 0009617544-2022-00068
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 07613327267914
• UDI-Public: 07613327267914
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/23/2022

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
• Device Operator: Health Professional
• Device Model Number: 48350951
• Device Catalogue Number: 48350951
• Device Lot Number: 157352
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/01/2022
• Initial Date FDA Received: 06/30/2022
• Supplement Dates Manufacturer Received: 08/23/2022
• Supplement Dates FDA Received: 09/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1