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

Device Problems Migration or Expulsion of Device (1395); Device Slipped (1584); Migration (4003)

Patient Problems Failure of Implant (1924); Injury (2348); No Code Available (3191)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

Event year is reported as 2020; however exact date of event is unknown.This report is for an unk - screws: matrixrib/unknown lot.Part and lot numbers are unknown; udi number is unknown.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.(b)(4).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 on (b)(6) 2020 that the patient underwent for a revision surgery for broken plate from matrixrib set which is chest wall deformity for pectus carinatum.The screws had popped out.It was unknown if the procedure completed successfully.The patient consequence was shifting of chest wall.Concomitant device reported: unknown matrixrib screws (part # unknown, lot # unknown, quantity unknown), unknown cable/wire (part # unknown, lot # unknown, quantity unknown).This complaint involves two (2) devices.This report is for (1) unk - screws: matrixrib.This is report 2 of 2 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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.

• Brand Name: UNK - SCREWS: MATRIXRIB
• Type of Device: SCREW,FIXATION,BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10614277
• MDR Text Key: 209449913
• Report Number: 8030965-2020-07620
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/05/2020
• Patient Sequence Number: 1
• Treatment: UNK - CABLE/WIRE; UNK - CABLE/WIRE
• Patient Outcome(s): Required Intervention
• Patient Age: 18 YR