MAUDE Adverse Event Report: SYNTHES GMBH 6.0MM THREADED SACRAL BAR 260MM; PIN, FIXATION, THREADED

Catalog Number 296.766S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hematoma (1884); Impaired Healing (2378)

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from (b)(6) reports an event as follows: it was reported that the patient underwent a procedure on an unknown date for fixation of a unilateral sacral fracture using dps sacral bar implant 260 mm with nuts and washers (stainless steel).The duration of follow up was 26 weeks.Healing was observed.An adverse event of hypotension and hypercreatinemia developed.Early implant associated complications includes hematoma.Re operation after index surgery was made because of impaired wound healing due to persisting hematoma.No further information is available.This report is for a 6.0mm threaded sacral bar 260mm.This is report 1 of 1 for (b)(4).

• Brand Name: 6.0MM THREADED SACRAL BAR 260MM
• Type of Device: PIN, FIXATION, THREADED
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): ELMIRA; 35 airport road; horseheads NY
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12627444
• MDR Text Key: 277399026
• Report Number: 8030965-2021-08647
• Device Sequence Number: 1
• Product Code: JDW
• UDI-Device Identifier: 07611819343283
• UDI-Public: (01)07611819343283
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K001720
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 296.766S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/01/2021
• 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 Age: 85 YR