MAUDE Adverse Event Report: ZIMMER SPINE INVIZIA, IMP.PLATE, 3L,57MM

Model Number N/A

Device Problems Break (1069); Fracture (1260)

Patient Problems Fall (1848); Head Injury (1879); Tissue Damage (2104)

Event Date 01/05/2016

Event Type  Injury  

Manufacturer Narrative

The device evaluation is anticipated, a follow up report will be sent upon completion of the product evaluation.Report one of two for the same event; see also 0002184052-2016-00006.

Event Description

The facility reported a broken plate and screw.The surgeon had a roh c4-c7 with extension c3-c4, evaluate fusion.He found one wing of the locking mechanism had broken off, discoloration of area soft tissue, and a broken screw at c7, which is the same location as where the broken lock was noted.It was reported that patient had fallen and struck head following the last c-spine surgery.The doctor did re-plate c6-c7 as he felt there was still some motion at that segment.

Manufacturer Narrative

(b)(4).

Event Description

The sales associate provided additional event details.It is reported the reason for the revision was adjacent segment disease and the broken lock and screw were identified during the revision surgery.The surgeon believes the fall caused the breakage.

Manufacturer Narrative

The returned 07.01617.004 (invizia, imp.Plt, 3l,57mm) from lot 62043674 was visually inspected by quality engineering.Initial inspection confirms the reported device condition; one of the device¿s four locking mechanisms is fractured.A functional assessment was not performed.According to information collected during correspondence with the field, the implant breakage was the result of external forces from an injury sustained by the patient following surgery.Implant breakage was not a result of product failure before or during surgery.The reported complaint is confirmed based on the item¿s received condition.The dhr (device history record) for the product lot was reviewed.There were no reported non-conformances or product deviations that could have contributed to the reported event.Upon incoming inspection, samples from the lot were verified as conforming for the following traits: physical dimensions, material certs, anodization, functional assessment, and workmanship/finish.There are no indications of manufacturing issues which could have contributed to this event.The root cause was determined to be the result of an incident/injury sustained by the patient following initial surgery.Supplemental report one of two for the same event; see also 0002184052-2016-00006-2.

• Brand Name: INVIZIA, IMP.PLATE, 3L,57MM
• Type of Device: PLATE
• Manufacturer (Section D): ZIMMER SPINE; 7375 bush lake road; minneapolis MN 55439
• Manufacturer (Section G): ZIMMER SPINE; 7375 bush lake road; minneapolis MN 55439
• Manufacturer Contact: michelle cole ; 7375 bush lake road; minneapolis, MN 55439 ; 9528325600
• MDR Report Key: 5408357
• MDR Text Key: 37423106
• Report Number: 0002184052-2016-00005
• Device Sequence Number: 1
• Product Code: KWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK111796
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/05/2016

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?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 07.01617.004
• Device Lot Number: 62043674
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/05/2016
• Initial Date FDA Received: 02/03/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 03/08/2016; 07/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention