MAUDE Adverse Event Report: STRYKER SPINE-US 9.5X90 POLYAXIAL SCREW; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Catalog Number 482619590

Device Problems Nonstandard Device (1420); Device Markings/Labelling Problem (2911); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/11/2019

Event Type  malfunction  

Manufacturer Narrative

An urgent medical device recall letter was sent on 01 july 2019 to the affected customers.The urgent medical device recall letter was sent to notify customers that the affected product has been voluntarily recalled by stryker and has already been removed from their inventory by the local representative.

Event Description

A screw labelled as 95 mm, was actually 100 mm in length.No patient involvement or adverse consequences to a patient.

Manufacturer Narrative

A visual inspection was performed and no visual non-conformances were identified but a dimensional inspection via calibrated ruler confirmed the screw shaft was 100mm in length instead of 90mm as marked.Complaint history records were reviewed for the lot number provided and no similar events were identified.Device history records were reviewed and no relevant manufacturing issues were identified.As the device was confirmed to be out of specification, a nonconformance was initiated.The result was determined to be human error during final inspection.A corrective action/preventative action was opened to further investigate and prevent recurrence.

Event Description

A screw labelled as 95 mm, was actually 100 mm in length.No patient involvement or adverse consequences to a patient.

• Brand Name: 9.5X90 POLYAXIAL SCREW
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8778453
• MDR Text Key: 150702275
• Report Number: 3005525032-2019-00070
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 07613327351576
• UDI-Public: 07613327351576
• Combination Product (y/n): N
• PMA/PMN Number: K170496
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 09/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 482619590
• Device Lot Number: B88751
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2019
• Date Manufacturer Received: 08/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1