MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - SCREWS: CMF; SCREW,FIXATION,BONE

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 06/26/2017

Event Type  Injury  

Manufacturer Narrative

510k: this report is for an unknown screws: cmf/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).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 synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2017 after preparing the patient for a partial hemimandibulectomy procedure, it was found that the provided surgical boxes did not contain the complete materials.The surgical team requested new materials from the facility, but they were not available.It was decided by the family and clinical team to abort the procedure instead of keeping the patient under general anesthesia while awaiting a new set of surgical boxes from the supplier.This report is for one (1) unk - screws: cmf.This is report 4 of 4 for (b)(4).

• Brand Name: UNK - SCREWS: CMF
• Type of Device: SCREW,FIXATION,BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10452233
• MDR Text Key: 204355927
• Report Number: 8030965-2020-06306
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/30/2020
• 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
• Treatment: UNK - DRILL BITS: CMF; UNK - INSERTION INSTRUMENTS: CMF; UNK - PLATES: CMF
• Patient Age: 26 YR