MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG NEURO SCREWS, CROSS-PIN, SELF-DRILLING, DIAM.1.5X5MM; IMPLANT

Catalog Number 92-15905

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 11/25/2014

Event Type  malfunction  

Event Description

It was reported that the surgeon was in the process of screwing in a screw (b)(4)) into a large pmma custom implant/product (b)(4) when the head detached from the body of the screw.

Manufacturer Narrative

Device not returned for evaluation as it was discarded by the hospital.If additional information is received it will be reported on a supplemental report.Device was discarded.

• Brand Name: NEURO SCREWS, CROSS-PIN, SELF-DRILLING, DIAM.1.5X5MM
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-79 111
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-79 111
• Manufacturer Contact: julie schoell ; boetzingerstr. 41; freiburg D-791-11 ; 76145120
• MDR Report Key: 4331345
• MDR Text Key: 5212661
• Report Number: 0008010177-2014-00350
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031659
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/25/2014

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 Catalogue Number: 92-15905
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/25/2014
• Initial Date FDA Received: 12/16/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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