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

Catalog Number 11-8999

Device Problem Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/20/2017

Event Type  Injury  

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 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
• Type of Device: POSTERIOR CERVICO-THORACIC FIXATION SYSTEM
• Manufacturer (Section D): SPINE WAVE, INC.; 3 enterprise drive; suite 210; shelton CT 06484
• Manufacturer (Section G): SPINE WAVE, INC.; 3 enterprise drive; suite 210; shelton CT 06484
• Manufacturer Contact: ronald smith ; 3 enterprise drive; suite 210; shelton, CT 06484 ; 2039449494
• MDR Report Key: 7130989
• MDR Text Key: 95329020
• Report Number: 3004638600-2017-00009
• Device Sequence Number: 1
• Product Code: NKG
• UDI-Device Identifier: 10840642111217
• UDI-Public: 10840642111217
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162369
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/28/2017
• 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): Required Intervention
• Patient Age: 69 YR