MAUDE Adverse Event Report: WARSAW ORTHOPEDICS GALAXY; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Catalog Number	7002526
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient underwent posterior cervical canal dilatation due to cervical spinal stenosis.Intra-operatively, the instrument broke.No fragment of the instrument remained inside the patient.No patient complication occurred as a result of the alleged event.
Additional Manufacturer Narrative
H6: product analysis: visual and optical examination identified that the breakage is consistent with excessive torque applied during tightening of the cen tral nut.This is consistent with over torque.Additional information: d10, h3, h6.If information is provided in the future, a supplemental report will be issued.

• Brand Name: GALAXY
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• MDR Report Key: 9614732
• Report Number: 1030489-2020-00092
• Device Sequence Number: 19502486
• Product Code: KWP
• UDI-Device Identifier: 00885074175058
• UDI-Public: 00885074175058
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K042524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2020

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 Catalogue Number: 7002526
• Device Lot Number: 0134086W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2020
• Initial Date Received by Manufacturer: 12/23/2019
• Supplement Date Received by Manufacturer: 05/27/2020
• Initial Report FDA Received Date: 01/22/2020
• Supplement Report FDA Received Date: 06/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR