MAUDE Adverse Event Report: SYNTHES TUTTLINGEN T-PLIF IMPLANT HOLDER; FORCEPS

Catalog Number 03.806.000

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 11/11/2014

Event Type  Injury  

Manufacturer Narrative

Additional narrative: product investigation: one t-plif implant holder (part 03.806.000, lot t957505, mfg apr 2011) was returned with the complaint that ¿the t-plif implant holder was rotating during insertion.A small tear occurred in the dura as a result of the implant holder rotating.¿ upon receipt of the device, the implant holder was found to be intact and in good condition, with moving parts functioning as intended, and is able to hold the implant with which it was returned (08.804.010) securely and releases it as designed; no rotational movement could be discerned.This complaint is unconfirmed.The drawings for this device were reviewed, no discrepancies were found between the drawing specifications and the returned device.The design is adequate for its intended use.This complaint condition is unconfirmed, this complaint could have occurred if the speed nut was not tightened, thus not holding the implant stable during insertion, as both the implant and implant holder were found to be in good working condition this complaint was likely a result of user error.Device 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

It was reported that the t-plif implant holder was rotating during insertion while the surgeon was performing a 4-5 transforaminal posterior lumbar inter-body fusion procedure (t-plif) on (b)(6) 2014.Reportedly the t-plif implant holder was rotating during insertion and a small tear occurred in the dura as a result of the implant holder rotating, the surgeon sewed up the dura and then continued with the surgery.There was a 15 minute time delay to sew up the patient another t-plif implant holder was not available, so that surgeon used an oblique posterior atraumatic lumbar (opal) spacer to successfully complete the surgery.There was a 5 minute time delay to switch from the t-plif to the opal spacer.There was a total delay of 20 minutes in the surgery.This is report 1 of 2 for (b)(4).

Manufacturer Narrative

Device is an instrument and is not implanted/explanted.Small tear in the dura as a result of the implant holder rotating.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The raw material which was delivered as lot #kr322626 and #221302 is corresponding to the specifications.The hardness was measured at the time of the manufacturing at 49hrc and was found to be good.No nonconformance reports were generated during production.The investigation could not be completed; no conclusion could be drawn, as the product is entering the complaint system.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: T-PLIF IMPLANT HOLDER
• Type of Device: FORCEPS
• Manufacturer (Section D): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 7853 2; GM 78532
• Manufacturer (Section G): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 7853 2; GM 78532
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4316672
• MDR Text Key: 12868014
• Report Number: 9680938-2014-10093
• Device Sequence Number: 1
• Product Code: HTD
• 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: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.806.000
• Device Lot Number: T957505
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/08/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2011
• 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
• Patient Age: 76 YR