MAUDE Adverse Event Report: WARSAW ORTHOPEDICS TIMESH; ORTHOSIS, SPINE, PLATE, LAMINOPLASTY, METAL

Catalog Number	853010WM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Muscle Weakness/Atrophy (1967); Neck Pain (2433); No Code Available (3191)
Date of Event	12/20/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Devices of multiple part/lot numbers were implanted during the procedure including: part: 853010wm / lot: 0463760w (x1) part: 853010wm/ lot: 0463700w (x1); part: 853010wm/ lot: 0438447w (x1); part: 853010wm/ lot: 0106859w (x1); part: 853-467/ lot: 0497212w (x7); part: 853-469 / lot: 0489775w (x9).Although it is unknown if any of these devices contributed to the reported event, we are filing this mdr for notification purposes.(b)(4).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.
Event or Problem Description
It was reported that on (b)(6) 2016, patient underwent a surgery due to ossification of posterior longitudinal ligament and stenosis of spinal canal.Post-op, patient had neck pain, limb weakness and 0 lower limb muscle strength.Due to which the patient underwent a revision surgery on (b)(6) 2016 in which posterior cervical decompression with vertex internal fixation was performed.The products came in contact with the patient.Patient was also reported with bleeding "after the surgery." after revision surgery patient had neck pain relief but 0 lower limb muscle strength.
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: TIMESH
• Common Device Name: ORTHOSIS, SPINE, PLATE, LAMINOPLASTY, METAL
• Manufacturer (Section D): WARSAW ORTHOPEDICS; 2500 silveus crossing; warsaw IN 46582
• MDR Report Key: 6259504
• Report Number: 1030489-2017-00124
• Device Sequence Number: 13687627
• Product Code: NQW
• UDI-Device Identifier: 00885074317458
• UDI-Public: 00885074317458
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K050082
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2016

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 853010WM
• Device Lot Number: 0463760W
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/23/2016
• Supplement Date Received by Manufacturer: 12/23/2016
• Initial Report FDA Received Date: 01/18/2017
• Supplement Report FDA Received Date: 09/28/2017
• 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: 44 YR