MAUDE Adverse Event Report: SPINEFRONTIER, INC INDUS ANTERIOR CERVICAL PLATE SYSTEM,

Model Number	IM71059-03
Medical Device Problem Codes	Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported incident was confirmed based on the following: evaluation of an image supplied by the end user, evaluation of the actual sample under magnification and design of an experiment to replicate the reported failure which focused on inserting a screw at a steep angle (not in line with the trajectory of the pilot hole).A review of the dfmea determine that this failure mode shearing of "debris (metal)" was identified during the design verification testing, and the risks were adequately mitigated in risk hazard analysis.Complaint vs sales trending identified (b)(4) other complaints relating to the shearing of the invue screws (b)(4).This occurrence level is a lower occurrence than the range specified by the risk hazard analysis therefore no risk document does not need to be updated in response to this complaint.Placing the screw at an angle outside of the 14 degrees recommendation was cited as the root cause of this occurrence, this is considered off label use.However, a review of invue max labeling: ifu-71-00001 invue max ifu and st-71-00001 invue max surgical technique, determined that updates are required to include shearing of the screw in the warnings and precautions sections.
Event or Problem Description
Spinefrontier received information form a clinician stating that metal strips sheared off the threads of the left c7 screw due to the severe angle between the plate and the screw.The shared screw was removed and replaced with a new one, it was reported that the new screw sheared in the same manner as the first, the second screw was left in-place.This incident occurred during a c6 -c7 posterior decompression and fusion case on (b)(6) male patient following a severe mva.

• Brand Name: INDUS ANTERIOR CERVICAL PLATE SYSTEM,
• Common Device Name: INDUS ANTERIOR CERVICAL PLATE SYSTEM
• Manufacturer (Section D): SPINEFRONTIER, INC; 350 main st; third floor; malden MA 02148
• MDR Report Key: 7616847
• Report Number: 3005977257-2018-00002
• Device Sequence Number: 19214690
• Product Code: KWQ
• UDI-Device Identifier: 00190361002130
• UDI-Public: (01)00190361002130(10)DL10
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K093776
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/19/2018

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: Physician
• Device Model Number: IM71059-03
• Device Lot Number: DL10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2018
• Was the Report Sent to FDA?: No
• Device Age: 3 MO
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2018
• Initial Report FDA Received Date: 06/19/2018
• 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: Life Threatening
• Patient Age: 60 YR