MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH 5.0MM LOCKING SCREW SLF-TPNG WITH T25 STARDRIVE RECESS 28MM SCREW, FIXATION, BONE

Catalog Number 212.208

Device Problem Unintended Movement (3026)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

The investigation could not be completed; no conclusion could be drawn, as no product was received. 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 synthes reports an event in (b)(6) as follows: it was reported that a patient underwent a surgical procedure on an unknown date, more than a year ago. The patient experienced persistent pain, and x-ray images taken showed screw failure. Concomitant device reported: unknown plate, (part # unknown, lot # unknown, quantity unknown). This is report 7 of 10 for (b)(4). This complaint has been updated with the 10 of 13 devices. Please see the linked complaint (b)(4) for the additional two devices.

• Brand Name: 5.0MM LOCKING SCREW SLF-TPNG WITH T25 STARDRIVE RECESS 28MM
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 9396195
• MDR Text Key: 168793326
• Report Number: 8030965-2019-70639
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (Y/N): N
• Reporter Country Code: PE
• PMA/PMN Number: K000682
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: COMPANY REPRESENTATIVE,FOREIG

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 11/09/2019

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 12/02/2019
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device Catalogue Number: 212.208
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/05/2019
• 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?

• Type of Device Usage: Unkown

Patient TREATMENT DATA

Date Received: 12/02/2019 Patient Sequence Number: 1