MAUDE Adverse Event Report: AESCULAP IMPLANT SYSTEMS S4 ELEMENT MIS POLYAXIAL SCREW 5.5X40MM; S4 ELEMENT IMPLANTS

Model Number ST053T

Device Problem Failure To Adhere Or Bond (1031)

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

Event Date 09/15/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: the complained screw arrived decontaminated with detached inlay.A visual inspection of the location insert was performed.The nose of the insert was bent.With the noses out of alignment, a reliable catch of the insert in the screw body is no longer given.The manufacturing documents have been checked and found to be according to specification valid during the time of production.The root cause for the problem is usage related.Corrective action: there is no for a capa.

Event Description

(b)(6).It was reported that for the second time the inlay has fallen out of the screw during a supply with s 4 element.The first screw with the same problem can no longer be found in the clinic.

• Brand Name: S4 ELEMENT MIS POLYAXIAL SCREW 5.5X40MM
• Type of Device: S4 ELEMENT IMPLANTS
• 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
• MDR Report Key: 6974571
• MDR Text Key: 90849725
• Report Number: 9610612-2017-00536
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K090657
• 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: 10/24/2017

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 Model Number: ST053T
• Device Catalogue Number: ST053T
• Device Lot Number: 52353003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2017
• Distributor Facility Aware Date: 10/24/2017
• Device Age: 3 MO
• Initial Date Manufacturer Received: 09/19/2017
• Initial Date FDA Received: 10/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/17/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other