MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG LOCKING SCREWS, CROSS-PIN, DIAM.2.0X12MM, (5/PACKAGE); IMPLANT

Catalog Number 50-20512

Device Problem Detachment Of Device Component (1104)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/08/2016

Event Type  malfunction  

Manufacturer Narrative

Device is not available for evaluation.If additional information is received it will be reported on a supplemental report.Head of screw was discarded at facility.Shaft is still in patient.

Event Description

It was reported that during a procedure to remove a plate that was originally implanted in (b)(6) 2016, the head of the screw holding it in place became detached.A drill was not used to loosen the screw it became detached by hand.The body of the screw is still implanted in the skull.

• Brand Name: LOCKING SCREWS, CROSS-PIN, DIAM.2.0X12MM, (5/PACKAGE)
• Type of Device: IMPLANT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11
• Manufacturer Contact: kelli dykstra ; boetzingerstr. 41; freiburg D-791-11 ; 76145120
• MDR Report Key: 5893144
• MDR Text Key: 52656871
• Report Number: 0008010177-2016-00192
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022185
• 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: 08/08/2016

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: Health Professional
• Device Catalogue Number: 50-20512
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/08/2016
• Initial Date FDA Received: 08/22/2016
• 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