MAUDE Adverse Event Report: STRYKER SPINE-US OASYS 3.5 X 80MM ROD; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION

Catalog Number	48552080
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/09/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device not returned.
Event or Problem Description
It was reported that rod was broken post-operatively.The patient underwent revision surgery on (b)(6) 2017 for replacement of hardware.
Event or Problem Description
It was reported that rod was broken post-operatively.The patient underwent revision surgery on (b)(6) 2017 for replacement of hardware.Update: the inspection of the returned product revealed that the rod didn't break.The rod was explanted successfully.This is a concomitant device.
Additional Manufacturer Narrative
The inspection of the returned product revealed that the rod didn't break.The rod was explanted successfully.This is a concomitant product.No further ingestion will be required.Therefore, no additional follow-up report will be filled.

• Brand Name: OASYS 3.5 X 80MM ROD
• Common Device Name: ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8189094
• Report Number: 0009617544-2018-00303
• Device Sequence Number: 19308101
• Product Code: NKG
• UDI-Device Identifier: 04546540371638
• UDI-Public: 04546540371638
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K151755
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2019

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: Health Professional
• Device Catalogue Number: 48552080
• Device Lot Number: 7XU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2019
• Initial Date Received by Manufacturer: 11/29/2018
• Supplement Date Received by Manufacturer: 02/27/2019
• Initial Report FDA Received Date: 12/21/2018
• Supplement Report FDA Received Date: 03/25/2019
• 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
• Patient Age: 8 YR