MAUDE Adverse Event Report: SYNTHES (USA) 2.0MM TI CRTX SCREW SLF-DRLG; SCREW, FIXATION, INTRAOSSEOUS

Catalog Number 401.061

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Pain (1994)

Event Type  Injury  

Event Description

It was reported a patient underwent hardware removal due to pain on (b)(6) 2014.The patient was originally implanted on (b)(6) 2013 with 2.0mm titanium curved sagittal spilt plate x1, 2.0mm titanium cortex screws x5 and 2.0mm titanium cortex screw x1.The explanted hardware was discarded by hospital facility and is not available evaluation.Per additional information received on (b)(6) 2014, the patient¿s initial procedure was an elective bilateral sagittal split.The surgeon indicated device(s) were loose.The broken or damaged hardware was removed; the procedure was completed successfully.This is 6 of 7 reports for (b)(4).

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device used for treatment not diagnosis.The part was not returned for evaluation.The lot number is unknown therefore a review of the device history record could not be completed.No conclusion could be drawn, as the part was not received.

• Brand Name: 2.0MM TI CRTX SCREW SLF-DRLG
• Type of Device: SCREW, FIXATION, INTRAOSSEOUS
• Manufacturer (Section D): SYNTHES (USA); 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 3658255
• MDR Text Key: 4194525
• Report Number: 2520274-2014-10081
• Device Sequence Number: 1
• Product Code: DZL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK963546
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 401.061
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/03/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 50