MAUDE Adverse Event Report: SYNTHES HAGENDORF T-PAL SPACER 10MM X 28MM 10MM HEIGHT; INTERVERTEBAL FUSION DEVICE W/BONE GRAFT, LUMBAR

Catalog Number 08.812.010

Device Problem Positioning Problem (3009)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/15/2015

Event Type  malfunction  

Event Description

It was reported that a t-pal spacer was turning prematurely during attempted insertion.The implant was removed and attempted to be reinserted but again turned prematurely.In an attempt to rule out the applicator as the cause of the issue, the implant was then placed on a different applicator but still turned prematurely prior to loosening the applicator.There is no allegation of complaint against the applicator.A new 10mm implant was then loaded on the applicator and surgery was successfully completed without further incident.A surgical delay of 15 minutes was reported.This report is 1 of 2 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: patient initials are (b)(6).Patient weight was not provided by reporter.A device history record review was performed for the subject device lot.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.The subject device has been received and is currently in the evaluation process.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

A product evaluation investigation was preformed: received 1 article of t-pal small, peek, sterile, height 10, part# 08.812.010 for manufacturing investigation.The wrench size 5.725mm of the t-pal implant is damaged.No ncrs were generated during production.During a visual inspection it was noticed that the area of the wrench size 5.725 is badly deformed.Therefore, the wrench size 5.725 cannot be measured anymore.These deformations only occur by applying high force on the t-pal implant, which is an indication of mishandling.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 10MM X 28MM 10MM HEIGHT
• Type of Device: INTERVERTEBAL FUSION DEVICE W/BONE GRAFT, LUMBAR
• Manufacturer (Section D): SYNTHES HAGENDORF; im bifang 6; hagendorf CH46 14; SZ CH4614
• Manufacturer (Section G): SYNTHES HAGENDORF; im bifang 6; hagendorf CH46 14; SZ CH4614
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4824647
• MDR Text Key: 18265047
• Report Number: 3003875359-2015-10255
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK100089
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 08.812.010
• Device Lot Number: 9281162
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 65 YR