MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH T-PAL SPACER APPLICATOR KNOB; INTERVERTEBAL FUSION DEVICE W/BONE GRAFT, LUMBAR

Catalog Number 03.812.004

Device Problem Fitting Problem (2183)

Patient Problem Not Applicable (3189)

Event Date 06/03/2018

Event Type  malfunction  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Patient information is not available for reporting.Device is an instrument and is not implanted/explanted.Complainant device is not expected to be returned for manufacturer review/investigation.(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.Device was used for treatment, not diagnosis.

Event Description

Device report from synthes on an event in (b)(6) as follows: it was reported that after disc and end plate preparation, the t-pal cage was inserted.Once inserted and rotated, a fluoroscopic control was requested.The cage was nicely sitting in the anterior portion of the vertebral body but was slightly over-rotated.However, decision was made by surgeons to leave the cage in this position, first attempt.At this stage, even though the applicator was in the release position, the surgeon couldn't pull it out without pulling back the cage as well.Decision was made to re-attach the cage and fully remove it and try again.Once both the applicator and cage were removed, they tested the applicator and saw it was working properly.In the interim, the or nurse had prepared the second applicator from the set attached the cage on it.They performed a second insertion attempt, this time under fluoroscopic control along all the insertion process.They could position the cage in its final position without over-rotation this time, second attempt problem.No consequences for the patient.This report is for one (1) t-pal spacer applicator handle.The surgery was prolonged about 5-10 minutes.Procedure was successfully completed.This report is 3 of 3 for (b)(4).

• Brand Name: T-PAL SPACER APPLICATOR KNOB
• Type of Device: INTERVERTEBAL FUSION DEVICE W/BONE GRAFT, LUMBAR
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK HÄGENDORF (CH); im bifang 6; haegendorf 4614 ; SZ 4614
• Manufacturer Contact: michael cote ; 1201 ward ave; west chester, PA 19380
• MDR Report Key: 7927817
• MDR Text Key: 122467271
• Report Number: 8030965-2018-56923
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 07611819414624
• UDI-Public: (01)07611819414624
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K151276
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.812.004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1