MAUDE Adverse Event Report: STRYKER-SPINE SAHARA ¿ STABILIZATION SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION

Catalog Number 5808-21436L10

Device Problem Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/08/2017

Event Type  malfunction  

Manufacturer Narrative

Stryker completed its acquisition of k2m, inc.(k2m) on (b)(6) 2018.As part of integration activities stryker spine performed a retrospective review of k2m post market surveillance complaints or the period 2017 to 2018.The purpose of this review was to assess reportability decisions and ensure consistency with the stryker corporate procedures and policies.As a result of that this mdr is being filed.Dimensional and material analysis: the device remains implanted; physical evaluation could not be performed.The respective manufacturing and inspection lot records were reviewed with all accepted parts being reported to specification.A review of the per surveillance report did not reveal any contributing information/trends.Patient presented a very tight disc space.Upon adjusting the device height, attempt was made to reach the 2nd adjustment level.It could not be confirmed that the second adjustment level was fully achieved (engaged).Follow-up suggested the implant was at the 1st adjustment.Adjustment to the 2nd level could not be confirmed therefore product collapse failure could not be concluded.

Event Description

A physician reported that a patient experienced subsidence of approximately 1mm of a sahara al expandable cage two or three weeks post-operatively.The device remaims implanted and no adverse consequence to the patient has been reported.

• Brand Name: SAHARA ¿ STABILIZATION SYSTEM
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION
• Manufacturer (Section D): STRYKER-SPINE; 600 hope parkway se; leesburg VA 20175
• Manufacturer (Section G): STRYKER SPINE-US; 2 pearl court; allendale 07401
• Manufacturer Contact: margarita karan ; 2 pearl court; allendale 07401 ; 2017608000
• MDR Report Key: 8949099
• MDR Text Key: 178370212
• Report Number: 3004774118-2019-01075
• Device Sequence Number: 1
• Product Code: OVD
• UDI-Device Identifier: 01088857213272
• UDI-Public: 1088857213272
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151481
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5808-21436L10
• Device Lot Number: DWLF
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other