MAUDE Adverse Event Report: STRYKER SPINE-FRANCE OASYS POLYAXIAL SCREW NON BIASED DIA 4.5 X 28; SPINAL INTERLAMINAL FIXATION ORTHOSIS

Catalog Number	48558528
Medical Device Problem Codes	Mechanical Problem (1384); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/18/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; performing a posterior cervical fusion of the c3 to t2, we had placed all 10 of 3.5x12mm screws in c3 - c7.We then placed 3 of the 4 of the 4.5 x 28mm screws.Two were placed in at both the left and right pedicles of t1 and then we had a screw in already inserted at t2 on the left side.The surgeon was inserting the final screw 4.5x26mm screw in a t t2 and as he was tightening, the screw head broke off, leaving the majority of the thread inside the vert body.We did not have a universal removal kit at the time and had to use a set to remove the entire thread.We also used all the 4.5 x 28mm screws, so we had to resort to using a 4.5x24mm screw.
Additional Manufacturer Narrative
Visual inspection; device history review; complaint history review; risk assessment.Manufacturing files were reviewed and no anomalies were found.Visual confirmation confirmed a separated tulip head from the threaded shank portion the probable root cause is the hard bone quality of the patient.
Event or Problem Description
It was reported that; performing a posterior cervical fusion of the c3 to t2, we had placed all 10 of 3.5x12mm screws in c3 - c7.We then placed 3 of the 4 of the 4.5 x 28mm screws.2 were placed in at both the left and right pedicles of t1 and then we had a screw in already inserted at t2 on the left side.The surgeon was inserting the final screw 4.5x26mm screw in at t2 and as he was tightening, the screw head broke off, leaving the majority of the thread inside the vert body.We did not have a universal removal kit at the time and had to use a set to remove the entire thread.We also used all the 4.5 x 28mm screws, so we had to resort to using a 4.5x24mm screw.

• Brand Name: OASYS POLYAXIAL SCREW NON BIASED DIA 4.5 X 28
• Common Device Name: SPINAL INTERLAMINAL FIXATION ORTHOSIS
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6104707
• Report Number: 0009617544-2016-00455
• Device Sequence Number: 10931530
• Product Code: KWP
• UDI-Device Identifier: 04546540596444
• UDI-Public: (01)04546540596444
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K151755
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2017

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: No Information
• Device Catalogue Number: 48558528
• Device Lot Number: 163147
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/18/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/15/2016
• Supplement Report FDA Received Date: 01/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 84 YR