MAUDE Adverse Event Report: SYNTHES BRANDYWINE ORACLE SPACER 40MM X 22MM 17MM HEIGHT/8 DEG ANG-STERIL; INTERVERTEBAL FUSION DEVICE W/BONE GRAFT, LUMBAR

Catalog Number 08.809.617S

Device Problems Display or Visual Feedback Problem (1184); Difficult To Position (1467); Packaging Problem (3007)

Patient Problem No Code Available (3191)

Event Date 01/22/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The complainant part was not explanted.The device is not available for manufacturer review/investigation.(b)(6).(b)(4) 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 (b)(4) reports an event in (b)(6) as follows: it was reported that the labeling on oracle cage was interchanged for "p - posterior" and "a - anterior." during a surgical procedure on (b)(6) 2016, the surgeon inserted the cage as labeled, but noticed that the 8ࠁngle pointed to the posterior part of the disc (kyphosis).The cage was removed and the "labeling failure" was discovered.The surgeon was able to reinsert the same cage by inserting it the other way around to address the "lordosis" in this segment.The surgery was prolonged by approximately five (5) minutes.The patient outcome was reportedly "okay." this report is 1 of 1 for (b)(4).

Manufacturer Narrative

Product investigation summary: although the device was not received for evaluation, a review of the device photographs was completed by the manufacturing facility.As it appears that the etching on the part may have been the ¿wrong way,¿ an escalation into correction has been initiated.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.Product photos evaluated.

• Brand Name: ORACLE SPACER 40MM X 22MM 17MM HEIGHT/8 DEG ANG-STERIL
• Type of Device: INTERVERTEBAL FUSION DEVICE W/BONE GRAFT, LUMBAR
• Manufacturer (Section D): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer (Section G): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5427402
• MDR Text Key: 38057699
• Report Number: 2530088-2016-10027
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK072791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Catalogue Number: 08.809.617S
• Device Lot Number: 5782869
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/16/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/12/2008
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR
• Patient Weight: 85