MAUDE Adverse Event Report: STRYKER SPINE-US OASYS TITANIUM TRANSITION ROD D6XL600 US; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION

Catalog Number	48553608
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	01/28/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that rod broke during bending.All broken fragments were retrieved.A surgical delay of 15 min was reported.No other adverse consequence was reported to the patient.
Additional Manufacturer Narrative
Method: labelling review, risk assessment.Result: one oasys titanium transition rod was confirmed by the stryker rep to have fractured.Manufacturing files were not reviewed because no lot was provided.Conclusion: the probable root cause is undetermined.Potential root causes could be: repeated bending and/or rods being manufactured prior to when the laser marking manufacturing process was updated to not create voids in the markings.If more information becomes available this complaint will be reopened.
Event or Problem Description
It was reported that rod broke during bending.All broken fragments were retrieved.A surgical delay of 15 min was reported.No other adverse consequence was reported to the patient.

• Brand Name: OASYS TITANIUM TRANSITION ROD D6XL600 US
• Common Device Name: ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 8349943
• Report Number: 0009617544-2019-00012
• Device Sequence Number: 13854610
• Product Code: NKG
• UDI-Device Identifier: 07613252601821
• UDI-Public: 07613252601821
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K151755
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2019

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 Catalogue Number: 48553608
• Device Lot Number: UNKNONW
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/28/2019
• Supplement Date Received by Manufacturer: 03/29/2019
• Initial Report FDA Received Date: 02/19/2019
• Supplement Report FDA Received Date: 04/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1