MAUDE Adverse Event Report: STRYKER SPINE-US OASYS 4.0 X 34MM POLYAXIAL SCREW; POSTERIOR CERVICAL SCREW SYSTEM

Model Number	48552438
Medical Device Problem Codes	Separation Failure (2547); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device remains implanted.
Event or Problem Description
A physician reported that an oasys polyaxial screw head disengaged post-operatively.Revision surgery has not been reported.
Additional Manufacturer Narrative
Corrected data: d.1: updated 'oasys 4.0 x 38mm polyaxial screw' to 'oasys 4.0 x 34mm polyaxial screw'.D.4: updated catalog # '48552438' to catalog # '48552434'.D.4: updated lot/serial no.'053129' to '170187'.D.4: updated gtin '(b)(4)' to '(b)(4)'.E.1: updated 'dr.(b)(6)' to 'dr.(b)(6)'.Visual, dimensional, material and functional analysis could not be performed as the device was not returned.However, review of provided x-rays confirm that the tulip of the oasys polyaxial screw implanted in the third level from the caudal end of construct had disengaged from its shank.It can be seen that the oasys construct spanned seven levels.The patient was also implanted with a three level plate and interbodies, both of which were located anterior to the oasys construct.A review of the device history was performed and there were no relevant manufacturing issues identified as all units met stryker specifications.A review of the complaint history records was performed and there were no similar complaints identified.Per surgical technique: delayed union or nonunion: internal fixation appliances are load sharing devices which are used to obtain alignment until normal healing occurs.In the event that healing is delayed, does not occur, or failure to immobilize the delayed/nonunion results, the implant will be subject to excessive and repeated stresses which can eventually cause loosening, bending or fatigue fracture.The degree or success of union, loads produced by weight bearing, and activity levels will, among other conditions, dictate the longevity of the implant.It is possible that this failure could have been a result of fatigue loading due to delayed fusion, causing stresses on the screw which could lead to tulip disengagement.
Event or Problem Description
A physician reported that an oasys polyaxial screw head disengaged post-operatively.Revision surgery has not been reported.

• Brand Name: OASYS 4.0 X 34MM POLYAXIAL SCREW
• Common Device Name: POSTERIOR CERVICAL SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 9638568
• Report Number: 0009617544-2020-00012
• Device Sequence Number: 319652
• Product Code: NKG
• UDI-Device Identifier: 04546540371850
• UDI-Public: 04546540371850
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K151755
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2020

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: Health Professional
• Device Model Number: 48552438
• Device Catalogue Number: 48552434
• Device Lot Number: 170187
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/09/2020
• Supplement Date Received by Manufacturer: 03/31/2020
• Initial Report FDA Received Date: 01/28/2020
• Supplement Report FDA Received Date: 04/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1