MAUDE Adverse Event Report: LANX, INC. LANX LATERAL-SA SYSTEM; INTERVERTEBRAL BODY FUSION DEVICE - OVD, MAX, MQP, ODP

Model Number 8630-0107

Device Problem Material Torqued (2980)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/11/2014

Event Type  malfunction  

Event Description

During final tightening of the bone screw, the driver hex tip broke off into the screw head and was not retrievable.There were no reports of intraoperative or postoperative adverse events.

• Brand Name: LANX LATERAL-SA SYSTEM
• Type of Device: INTERVERTEBRAL BODY FUSION DEVICE - OVD, MAX, MQP, ODP
• Manufacturer (Section D): LANX, INC.; broomfield CO
• Manufacturer Contact: gary turner ; 310 interlocken parkway; suite 120; broomfield, CO 80021 ; 3034437500
• MDR Report Key: 3802446
• MDR Text Key: 16449457
• Report Number: 3004485144-2014-00002
• Device Sequence Number: 1
• Product Code: OVD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123767
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 02/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8630-0107
• Device Lot Number: TU00090F
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/14/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/11/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: 8607-5540 SCREW; 8607 SCREW
• Patient Age: 33 YR