MAUDE Adverse Event Report: SYNTHES (USA) T-PAL TRIAL SPACER 12MM X 32MM 12MM HEIGHT; TEMPLATE

Catalog Number 03.812.512

Device Problem Break (1069)

Patient Problem Sedation (2368)

Event Date 08/01/2014

Event Type  Injury  

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported the tip of the sleeve broke off in the handle and was stuck during surgery.The broken piece was able to be removed after the surgery was completed.The surgery was prolonged one hour.It was reported there was no serious injury to the patient due to this event.This is report 5 of 5 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Device is an instrument and is not implanted/explanted.Initial reporter phone: (b)(6).Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Device was 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

During a case on (b)(6) 2014, while using the transforminal posterior atraumatic lumbar cages the trial implant tip broke off completely and the travios implants were used which is what caused the delay to surgery.

• Brand Name: T-PAL TRIAL SPACER 12MM X 32MM 12MM HEIGHT
• Type of Device: TEMPLATE
• Manufacturer (Section D): SYNTHES (USA); 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4044629
• MDR Text Key: 4906003
• Report Number: 2520274-2014-13362
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.812.512
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/03/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention