MAUDE Adverse Event Report: SYNTHES HAGENDORF T-PAL SPACER APPLICATOR INNER SHAFT; INTERVERTEBAL FUSION DEVICE W/BONE GRAFT, LUMBAR

Catalog Number 03.812.003

Device Problem Break (1069)

Patient Problems Sedation (2368); No Code Available (3191)

Event Date 01/11/2017

Event Type  Injury  

Manufacturer Narrative

Additional device product code used lxh.(b)(4).Device is an instrument and is not implanted/explanted.Device is expected to be returned for manufacturer review/investigation, but has not been received yet.(b)(6).(b)(4).Device history records review was completed for part# 03.812.003, lot# 9197797.Manufacturing location: (b)(4), manufacturing date: nov 05, 2014.No non conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Lot number 89598887 does not match to article 03.812.003.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 follow: it was reported that on (b)(6) 2017, patient underwent plif (posterior lumbar interbody fusion) for the lumbar spinal canal stenosis.During the procedure, the surgeon applied plif from l3 to l5.At first, he inserted an implant (part # unknown) between l4 and l5.Next, he widened the disc space of l3/l4 and tried to insert the reported t-pal implant 11mm between l3 and l4.Without a trial, he inserted the reported implant between the disc space of l3/l4 and completely turned the implant according to the surgery instructions.When he tried to release the implant, it remained in the turned position rigidly and he could not release the implant from the holder.He could not pull up the inserter because it might have interfered with the dura.So, he decided to release the implant in the body as follows: he removed the implant holder handle and the applicator knob.Then, he tried to release the implant from the implant holder shaft.Also, he twisted the implant holder shaft.But the situation was not improved.He inserted the mucosal elevator in the gap of the implant holder shaft to release the implant forcibly.But the situation was not improved.He used the needle holder and tried to raise the shaft gradually by reverse hammering.However, the implant completely stuck with endplates.He raised the shaft and moved it to anterior and posterior directions.He held the trial shaft upside down and tried to move the tip of the implant straight against the implant holder shaft.But the situation was not improved.He repeated abovementioned procedures.Then, the connecting section of the shaft broke.The finger-like catcher on the tip of shaft broke, too.So, he removed those broken parts.At last, he shaved the pivotal sections of the implant by the airtome (brand name of a surgical instrument to grind bones).Next, he removed the rest of the finger-like catcher.Finally, he confirmed that no fragment left in the body by checking x-ray images.The entire surgery was delayed for approximately ninety five (95) minutes.There was no information available about patient and surgical outcome.Concomitant medical products: implant (part# unknown, lot# unknown, quantity 1); mucosal elevator (part# unknown, lot# unknown, quantity 1); needle holder (part# unknown, lot# unknown, quantity 1); applicator outer shaft (part# 03.812.001, lot# unknown, quantity 1); applicator knob (part# 03.812.004, lot# unknown, quantity 1).This report is for one (1) t-pal spacer applicator inner shaft.This is report 1 of 2 for (b)(4).

Manufacturer Narrative

A manufacturing investigation was performed.One (1) applicator inner shaft, part # 03.812.003, lot # 9197797 received.The article is in a used condition.The fork at the tip of the part is broken off.Due to heavy damage of the t-pal small cage h11 peek implant 08.812.011s no dimensional inspection by cmm (coordinate measuring machine) was possible.A part of the implant is missing; especially the drawing zero points and the entire area where the implant 08.812.011s was connected to the applicator inner shaft 03.812.003.In accordance to the cmm data protocol all results were within specification.It was determined a production fault was not the cause for the difficulties by releasing the implant (08.812.011s) of the holder (03.812.003) as described under the reported issue.No manufacturing related issue was identified and/or confirmed, therefore review to the specific prm and prm line is not applicable.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.

• Brand Name: T-PAL SPACER APPLICATOR INNER SHAFT
• Type of Device: INTERVERTEBAL FUSION DEVICE W/BONE GRAFT, LUMBAR
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf PA CH461 4; SZ CH4614
• Manufacturer (Section G): SYNTHES HAGENDORF; im bifang 6; hagendorf CH461 4; SZ CH4614
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6287013
• MDR Text Key: 66116728
• Report Number: 2520274-2017-10322
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151276
• 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: 01/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 03.812.003
• Device Lot Number: 9197797
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/05/2014
• 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
• Treatment: ONE (1) UNKNOWN IMPLANT; ONE (1) UNKNOWN MUCOSAL ELEVATOR; ONE (1) UNKNOWN NEEDLE HOLDER; PART# 03.812.001, LOT# UNKNOWN, QUANTITY 1; PART# 03.812.004, LOT# UNKNOWN, QUANTITY 1
• Patient Outcome(s): Required Intervention