MAUDE Adverse Event Report: JOLIFE AB - 3005445717 BONE SCREWS, MP, CROSS-PIN, DIAM.2.0X5MM,(5/PACKAGE); IMPLANT

Catalog Number 92-20105

Device Problems Fracture (1260); Difficult to Remove (1528)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/27/2018

Event Type  malfunction  

Manufacturer Narrative

Device is not available for evaluation.If additional information is received it will be reported on a supplemental report.Screw head was discarded at the user facility.

Event Description

It was reported by a company representative that a screw had fractured during bilateral sagital split osteotomy procedure.It was stated further that the tip of the screw was left in the patient.

• Brand Name: BONE SCREWS, MP, CROSS-PIN, DIAM.2.0X5MM,(5/PACKAGE)
• Type of Device: IMPLANT
• Manufacturer (Section D): JOLIFE AB - 3005445717; scheelevagen 17; ideon science park; lund SE-22 3 70; SE SE-223 70
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11
• Manufacturer Contact: hans geiger ; boetzingerstr. 41; freiburg D-791-11 ; 76145120
• MDR Report Key: 7463329
• MDR Text Key: 106979935
• Report Number: 0008010177-2018-00035
• 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: 04/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 92-20105
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/27/2018
• 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