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

Catalog Number	482619590
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/11/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
A screw labelled as 95 mm, was actually 100 mm in length.No patient involvement or adverse consequences to a patient.
Additional 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 or Problem 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
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8778453
• Report Number: 3005525032-2019-00070
• Device Sequence Number: 11429511
• Product Code: NKB
• UDI-Device Identifier: 07613327351576
• UDI-Public: 07613327351576
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K170496
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2019

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: 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
• Initial Date Received by Manufacturer: 06/11/2019
• Supplement Date Received by Manufacturer: 08/19/2019
• Initial Report FDA Received Date: 07/10/2019
• Supplement Report FDA Received Date: 09/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1