MAUDE Adverse Event Report: STRYKER SPINE-FRANCE OASYS MIDLINE OCCIPUT PLATE ASSY LARGE; SPINAL INTERLAMINAL FIXATION ORTHOSIS

Model Number	48551046
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Pain (1994); Injury (2348)
Date of Event	05/10/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that; patient was in a neck collar for 6 weeks, patient then removed collar and allegedly heard a clunk and reported associated pain.Patient came emergency.Imaging noted that the c6 screws were pulled out and c2 unilateral translaminar screw as well.The account did not notice that the occiput plate was broken during imaging but during the revision procedure it was reported as broken.Physician removed the occipital plate and replaced it with the same part and extended the fusion to t2 (t1 and t2 screws were added while c1 and c2 were left uninstrumented).
Additional Manufacturer Narrative
Method: risk assessment; result: manufacturing files were not reviewed due to no parts or lot provided.Conclusion: the possible root causes include: improper construct, set screws not tightened correctly; excessive load due to unstable construct; excessive load due to patient anatomy/pathology; patient performs strenuous post-op activities; surgeon applying too much torque to seat the screw head.
Event or Problem Description
It was reported that; patient was in a neck collar for 6 weeks, patient then removed collar and allegedly heard a clunk and reported associated pain.Patient came emergency.Imaging noted that the c6 screws were pulled out and c2 unilateral translaminar screw as well.The account did not notice that the occiput plate was broken during imaging but during the revision procedure it was reported as broken.Physician removed the occipital plate and replaced it with the same part and extended the fusion to t2 (t1 and t2 screws were added while c1 and c2 were left uninstrumented).

• Brand Name: OASYS MIDLINE OCCIPUT PLATE ASSY LARGE
• Common Device Name: SPINAL INTERLAMINAL FIXATION ORTHOSIS
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6614001
• Report Number: 0009617544-2017-00234
• Device Sequence Number: 18851746
• Product Code: KWP
• UDI-Device Identifier: 04546540616555
• UDI-Public: (01)04546540616555
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K151755
• 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): 08/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 48551046
• Device Catalogue Number: 48551046
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/10/2017
• Supplement Date Received by Manufacturer: 05/10/2017
• Initial Report FDA Received Date: 06/06/2017
• Supplement Report FDA Received Date: 08/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention