MAUDE Adverse Event Report: SYNTHES USA PLIVIOSREV 15*11 8°; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Catalog Number 889.515S

Device Problems Crack (1135); Material Fragmentation (1261)

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

Event Date 05/26/2015

Event Type  malfunction  

Manufacturer Narrative

Device broke intra-operatively and was not implanted or explanted.(b)(6).Device is not distributed in the united states, but is similar to a device marketed in the us.Product investigation summary: the investigation of the cage has shown that the input side of instrument is in multiple parts with pieces broken off.Due to this damage, and without further information pertaining to the event, the exact root cause cannot be determined.However, it is likely that a mechanical overload situation during the application led to the significant deformation / breakage of cage.Without a valid lot number for the device, a review of the device history records could not be requested.Based upon the visual inspection/evaluation, however, no product fault could be detected.Device used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from synthes europe reports an event in (b)(6) as follows: it was reported that a plivios revolution cage cracked/fragmented intra-operatively during a surgical procedure on (b)(6) 2015.The surgeon substituted the broken device with a pelvios cage peek.Further details surrounding the incident and patient outcome are unknown.This report is 1 of 1 for (b)(4).

• Type of Device: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES USA
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5013433
• MDR Text Key: 23427658
• Report Number: 2520274-2015-15299
• Device Sequence Number: 1
• Product Code: MQP
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Report Date: 06/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 889.515S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/18/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 65 YR