MAUDE Adverse Event Report: SYNTHES USA T-PLIF IMPLANT HOLDER; FORCEPS, GEN & PLASTIC SURGERY

Catalog Number 389.266

Device Problem Break (1069)

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

Event Date 12/07/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device is an instrument and is not implanted or explanted.Per facility, the complainant part has been discarded and is no longer available for evaluation.(b)(6).Investigation could not be completed and no conclusion could be drawn as no device was returned.Without a lot number, the device history record review could not be requested.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

Device report from synthes (b)(4) reports an event as follows: it was reported that the tip of a t-plif implant holder broke during a transforaminal posterior lumbar interbody fusion (t-plif) procedure at the l5-s1 disc level on (b)(6) 2015.The surgeon was using the instrument to insert the allograft spacer into the patient's disc space when the breakage occurred.Another instrument was available for use in the operating room.Due to this event, the operative time was extended by ten (10) minutes.The procedure was completed successfully.This report is 1 of 1 for (b)(4).

• Brand Name: T-PLIF IMPLANT HOLDER
• Type of Device: FORCEPS, GEN & PLASTIC SURGERY
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): SYNTHES USA
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5324491
• MDR Text Key: 34277932
• Report Number: 2520274-2015-18085
• Device Sequence Number: 1
• Product Code: GEN
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 389.266
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/08/2015
• Initial Date FDA Received: 12/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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