MAUDE Adverse Event Report: AESCULAP IMPLANT SYSTEMS S4 SET SCREW NEW VERSION; BONE SCREW

Model Number SW790T

Device Problem Material Fragmentation (1261)

Patient Problem No Information (3190)

Event Date 10/22/2015

Event Type  Injury  

Manufacturer Narrative

Manufacturing site evaluation: on-going.

Event Description

Country of complaint: (b)(6).First surgery: (b)(6) 2015: elements-provision on l4-l5.Revision surgery: (b)(6) 2015, because t-lif cage not fully seated.A part of the threaded was dissolved.Broken part was salvaged.Involved component: st075t / s4 element mis polyaxial screw, lot number: 52053214.

Manufacturer Narrative

The pedicle screw arrived with a detached inlay.The set screw was returned with a sheared off thread, which was returned.Visual evaluation using "keyence vhx 600d" was completed.The investigation of the set screw (sw790t) showed that the thread was partially bent and sheared off.The bottom of the set screw exhibits unusual wear marks, caused through motions of the rod.This is an indication that the rod was not tightly fixed.The investigation of the pedicle screw showed the thread in the top of the screw was damaged and bent.Manufacturing documents were reviewed and found to be according to specification during the time of production.The damaged threads and the contact pattern on the bottom of the set screw are indications of cross threading.The root cause is user related.Corrective / preventive action is not required.

• Brand Name: S4 SET SCREW NEW VERSION
• Type of Device: BONE SCREW
• Manufacturer (Section D): AESCULAP IMPLANT SYSTEMS; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP IMPLANT SYSTEMS; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 5240365
• MDR Text Key: 31764831
• Report Number: 3005673311-2015-00168
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K032219
• 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,Followup
• Report Date: 05/23/2016

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: No Information
• Device Model Number: SW790T
• Device Catalogue Number: SW790T
• Device Lot Number: 52129006
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 10/28/2015
• Initial Date Manufacturer Received: 10/22/2015
• Initial Date FDA Received: 11/20/2015
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other