MAUDE Adverse Event Report: STRYKER SPINE-FRANCE OASYS 3.5 X 12MM POLYAXIAL SCREW; SPINAL INTERLAMINAL FIXATION ORTHOSIS

Model Number	48552312
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/10/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; screws kept stripping as soon as any resistance was felt.
Additional Manufacturer Narrative
Method: device history review; complaint history review; risk assessment; results: device inspection was not completed due to no parts being returned for examination.Manufacturing records for this product were reviewed and no anomalies were found.Conclusion: the root cause is undetermined and is multifactorial.
Event or Problem Description
It was reported that; screws kept stripping as soon as any resistance was felt.

• Brand Name: OASYS 3.5 X 12MM POLYAXIAL SCREW
• Common Device Name: SPINAL INTERLAMINAL FIXATION ORTHOSIS
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6553976
• Report Number: 0009617544-2017-00190
• Device Sequence Number: 10963242
• Product Code: KWP
• UDI-Device Identifier: 04546540371676
• UDI-Public: (01)04546540371676
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K142741
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2017

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 Model Number: 48552312
• Device Catalogue Number: 48552312
• Device Lot Number: 146414
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/11/2017
• Supplement Date Received by Manufacturer: 04/11/2017
• Initial Report FDA Received Date: 05/09/2017
• Supplement Report FDA Received Date: 08/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1