MAUDE Adverse Event Report: OBERDORF : SYNTHES PRODUKTIONS GMBH; INTERVERTEBAL FUSION DEVICE W/BONE GRAFT, LUMBAR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 12/01/2017

Event Type  Injury  

Manufacturer Narrative

Patient id/initials, age/date of birth and weight are unknown.Device has not been explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Contact phone number was not provided.(b)(4).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.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 to prepare the disc space for the insertion of the tlif cage, the surgeon used kerrisons and rongeurs.After that, the surgeon used the t-pal shavers and determined that the definitive implant cage should be a tpal small 10 mm; no trial implants were used.Once filled in with autolog bone from the patient and loaded on the tpal inserter, the cage was given to the surgeon for implantation.To insert the cage, some heavy hammering was needed.To both help the cage progress and rotate, in several occasions the t-pal inserter was hammered while maintaining the applicator handle medially.Under fluoroscopy, the cage was positioned according to the surgical technique recommendations.To release the cage, the surgeon pushed the security ring down and turned the handle counterclockwise until it stopped.The applicator did not disengage from the implant.To help with removing the instrument, the surgeon decided to disassemble the handle and external applicator to leave only the internal applicator.Then he was able to remove the instrument.However, the cage had moved back.With the instrument 394.572, the surgeon tried to reposition and push the implant but it did not work.The surgeon decided to leave the cage partially rotated.There were no patient consequences.Concomitant devices: graft pusher (part 394.572, lot unknown, quantity 1); hammer (part/lot unknown, quantity 1).This report is for an unknown tlif cage.This is report 4 of 4 for (b)(4).

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

There was approximately 15-20 minutes surgical delay due to time required to disassemble the instrument, remove it from patient, try repositioning the implant, and check with x-ray.Surgery was completed successfully except that the cage could not be perfectly positioned according to surgical technique recommendations.

• Type of Device: INTERVERTEBAL FUSION DEVICE W/BONE GRAFT, LUMBAR
• Manufacturer (Section D): OBERDORF : SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf ; SZ
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7154070
• MDR Text Key: 96027637
• Report Number: 8030965-2017-51005
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention