MAUDE Adverse Event Report: BIOMET SPINE - BROOMFIELD SPF SPINAL FUSION STIMULATOR; IMPLANTABLE STIMULATOR

Model Number N/A

Device Problem Material Separation (1562)

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

Event Date 05/05/2015

Event Type  malfunction  

Manufacturer Narrative

The biomet spine implantable spinal fusion stimulators physician¿s manual & full prescribing information for spf plusmini, spf - xl iib establishes the following ¿handling¿ instructions in the ¿precautions¿: ¿do not disconnect the leads from the cathodes during the surgical procedure.¿ different from what is instructed in handling precaution notice of the biomet spine spf physician¿s manual, the surgeon utilized a minimally invasive surgical technique which requires the detachment and disconnection of the lead/cathode connectors pre-operatively or prior to implantation to permit him to pull the lead and cathode apart; thus, allowing passage one of those under the patient¿s skin line before reattaching it.Even though, the physician didn¿t follow the corresponding product ifu rendering the product inoperable for use, the unfavorable event of disengagement of the dbs cable from the connector could also occur during explantation.Based on the results of evaluation the disengagement of the dbs cable from the male pin connector crimp is most likely caused by the overlap of the actual pull force yield of this connection (9.3 to 18 pounds) and the male pin-female socket connection (2.5 to 13.3 pounds).This overlapping issue was also aggravated by an apparent inadequate crimping equipment adjustment which in turn caused an increase in the overlapping range between both connections.The risk of having the dbs cable disengaged from the male pin connector crimp during the implantable stimulator explantation procedures is not significant as at this stage since therapeutic treatment has already completed and that the male pin connector will remain covered by the pin sleeve, thus preventing direct contact of the titanium pin with human tissue.The patient would have completed their therapeutic treatment as intended and there would be no adverse effect during subsequent mri testing post-explantation.(b)(4).

Event Description

The sales associate reported that for the past three years, pre-operatively the surgeon disconnects the cathodes from their corresponding unit leads in order to conduct stimulator implantation using a minimal invasive mis procedure.During a procedure on (b)(6), 2015 the cable of the stimulator disengaged (separated) from the male pin connector crimp joint and therefore was unable to be used in the surgery.No adverse events were reported.

• Brand Name: SPF SPINAL FUSION STIMULATOR
• Type of Device: IMPLANTABLE STIMULATOR
• Manufacturer (Section D): BIOMET SPINE - BROOMFIELD; 310 interlocken parkway; suite 120; broomfield CO 80021
• Manufacturer (Section G): BIOMET SPINE - BROOMFIELD; 310 interlocken parkway; suite 120; broomfield CO 80021
• Manufacturer Contact: michelle cole ; 310 interlocken parkway; suite 120; broomfield, CO 80021 ; 3034437500
• MDR Report Key: 5140335
• MDR Text Key: 28347023
• Report Number: 3004485144-2015-00061
• Device Sequence Number: 1
• Product Code: LOE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PP850035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Report Date: 09/10/2015

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 Expiration Date: 12/01/2016
• Device Model Number: N/A
• Device Catalogue Number: 10-1335M
• Device Lot Number: 222550
• Other Device ID Number: SEE H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/06/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1