MAUDE Adverse Event Report: SPINE WAVE, INC. PROFICIENT POSTERIOR CERVICAL SPINE SYSTEM; POSTERIOR CERVICO-THORACIC FIXATION SYSTEM

Catalog Number	11-8999
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/20/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Returned for evaluation were the two locking screws replaced at the c2 level.A thorough visual examination was performed.Both units exhibited signs of wear consistent with surgical use.The locking screw threads displayed no abnormalities and functioned as intended upon evaluation.A review of the device history record found no non-conformances to specification.Based on the results of our evaluation, no definitive conclusion can be drawn.
Event or Problem Description
At approximately 6 weeks post-operatively, it was noted on radiographs that two locking screws were dettached from the screw heads at the c2 level.A surgical procedure was performed at which time the locking screws at the c2 level were removed and replaced.The patient is recovering successfully.

• Brand Name: PROFICIENT POSTERIOR CERVICAL SPINE SYSTEM
• Common Device Name: POSTERIOR CERVICO-THORACIC FIXATION SYSTEM
• Manufacturer (Section D): SPINE WAVE, INC.; 3 enterprise drive; suite 210; shelton CT 06484
• MDR Report Key: 7130989
• Report Number: 3004638600-2017-00009
• Device Sequence Number: 13778191
• Product Code: NKG
• UDI-Device Identifier: 10840642111217
• UDI-Public: 10840642111217
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K162369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/20/2017

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: Physician
• Device Catalogue Number: 11-8999
• Device Lot Number: 662R165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2017
• Initial Report FDA Received Date: 12/19/2017
• 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: 69 YR