MAUDE Adverse Event Report: SYNTHES BETTLACH SYNFIX(TM)-LR TRIAL IMPL 8DEG DEPTH 26MM/W 32MM/H 13.5MM; TEMPLATE

Catalog Number 03.802.000

Device Problems Fitting Problem (2183); Device-Device Incompatibility (2919)

Patient Problem Sedation (2368)

Event Date 11/24/2014

Event Type  Injury  

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that during the procedure, when putting the trial by using the handle for trial implant, straight.After insertion , the trial suddenly disengaged after certain times of impaction.The surgeon had failed to reengage manually because the locking of the trial handle is at the tip.However the locking knob was blocking by muscle and retractors as the procedure was alif.Finally, the surgeon had to remove more patient's bony structure to loosen the trapped trail.The sizer of synfix lr was cosmetically damaged as this was caused when removing the bony structure by blur.Removed bony structure , endplate of vertebra to enlarge the disc space for loosening the trial trapped.The case was prolonged 90 minutes because of this issue.This report is 1 of 2 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Without a lot number the device history record review and 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

No nonconformance reports were generated during production that would contribute to the complaint condition.The review of the device history record shows that there were no issues during the manufacture of the product that would contribute to the complaint condition.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Patient is reportedly good.

• Brand Name: SYNFIX(TM)-LR TRIAL IMPL 8DEG DEPTH 26MM/W 32MM/H 13.5MM
• Type of Device: TEMPLATE
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach PA 19380 CH2; SZ 19380 CH25
• Manufacturer (Section G): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH25 44; SZ CH2544
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4349274
• MDR Text Key: 5200288
• Report Number: 2520274-2014-15515
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 03.802.000
• Device Lot Number: 2195788
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/15/2015
• 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