MAUDE Adverse Event Report: BIOMET SPINE - BROOMFIELD SET SCREW 5.5MM ROD TI

Model Number N/A

Device Problem Bent (1059)

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

Event Date 05/04/2016

Event Type  Injury  

Manufacturer Narrative

Lot numbers tc51452 and tc60020.The device evaluation is anticipated, a follow up report will be sent upon completion of the product evaluation.Report one of two for the same event, see also 3004485144-2016-00096.

Event Description

The sales associate reported screws that were damaged during surgery.The doctor was performing a lateral fusion procedure with telluride system.The set screw was bent as there was difficulty coming down on the rod, and the pedicle screw end tip was bent.

Manufacturer Narrative

The returned device was visually evaluated revealing that the set screw had retained some thread damage.It is likely that the screw was not fully aligned when seated within the tulip head.The complaint is confirmed.The dhr shows that there were no nonconformances or manufacturing issues noted that may have contributed to the event.The reporting rep noted that the patient in the procedure had hard bone meaning this likely contributed to the damages that occurred with the implants.It is also likely that the set screw was misaligned upon insertion, leading to the thread deformation that is seen.

• Brand Name: SET SCREW 5.5MM ROD TI
• Type of Device: SET SCREW
• 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: 5694674
• MDR Text Key: 46397237
• Report Number: 3004485144-2016-00095
• Device Sequence Number: 1
• Product Code: KWP
• Combination Product (y/n): N
• PMA/PMN Number: PK100888
• 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: 05/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 7703-1600
• Device Lot Number: SEE H10
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/04/2016
• Initial Date FDA Received: 06/02/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/01/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 52 YR