MAUDE Adverse Event Report: STRYKER INSTRUMENTS-FREIBURG SPINEMAP® 3D 3.0 - SOFTWARE; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number 6002-670-000

Device Problem Image Orientation Incorrect (1305)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/26/2018

Event Type  malfunction  

Event Description

It was reported that during a spine surgery at the user facility, the device was inaccurate.The surgeon performed a second scan using fluoroscopy in order to successfully complete the procedure.There was not a clinically significant delay and there were no adverse consequences.

Manufacturer Narrative

It was determined after receiving further clarification from the customer that this event was not a reportable event per cfr 21, part 803.The event was related to another manufacturers device.The customer has alerted the other manufacturer of the product malfunction.This supplemental is being filed to identify a mdr was not required for this event as the event was not related to a stryker device.

Event Description

It was reported that during a spine surgery at the user facility the device was inaccurate.The surgeon performed a second scan using fluoroscopy in order to successfully complete the procedure.There was not a clinically significant delay and there were no adverse consequences.

• Brand Name: SPINEMAP® 3D 3.0 - SOFTWARE
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-FREIBURG; boetzingerstr. 41; freiburg MI D-791 11
• Manufacturer (Section G): STRYKER INSTRUMENTS-FREIBURG; boetzingerstr. 41; freiburg D-791 11
• Manufacturer Contact: zach baker ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 7541340
• MDR Text Key: 109229202
• Report Number: 0001811755-2018-01010
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• PMA/PMN Number: K141941
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6002-670-000
• Device Lot Number: VERSION 3.0-45
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1