MAUDE Adverse Event Report: SYNTHES GMBH UNK - PSI IMPLANTS; PLATE, CRANIOPLASTY, PREFORMED, NONALTERABLE

Catalog Number UNK - PSI IMPLANTS: TRAUMA

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

Patient Problems Unspecified Infection (1930); Non-union Bone Fracture (2369)

Event Type  Injury  

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.Additional narrative: 510k: this report is for an unknown psi implant.Device available for evaluation: 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

Reported user experience survey for the trumatch graft cage - long bone system.1.Have you used trumatch® graft cage ¿ long bone implants? -yes.2.Please include the total number (or best estimate) of procedures you have performed utilizing trumatch® graft cage ¿ long bone implants in skeletally mature populations.2.3.Please include the total number (or best estimate) of procedures you have performed utilizing trumatch® graft cage ¿ long bone implants in skeletally immature populations.0.4.Please estimate how many procedures were conducted for each clinical condition utilizing trumatch® graft cage ¿ long bone implants in skeletally mature and skeletally immature populations.Posttraumatic 2.Defect 0; non-union 0; infected 0; non-union 0; osteomyelitis 0; tumors 0; tumor-like diseases 0.5.Please estimate how many procedures were conducted in each of the following anatomical locations utilizing trumatch® graft cage ¿ long bone implants in both skeletally mature and skeletally immature populations.Humerus 0; femur 2; tibia 0.6.Please estimate the average patient follow-up time frame (in weeks) when utilizing the various trumatch® graft cage ¿ long bone implants in both skeletally mature and skeletally immature populations.52.7.If not using trumatch® graft cage ¿ long bone implants, which devices would you utilize and why (describe devices and techniques)? -no other device utilized would utilize antibiotic cement spacer followed by bone grafting.8.Have you experienced any complications directly related to trumatch® graft cage ¿ long bone implants (not including rigid fixation devices)? yes.This report is for one (1) (b)(4).This is report 1 of 1 for complaint unk - psi implants.

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 - PSI IMPLANTS
• Type of Device: PLATE, CRANIOPLASTY, PREFORMED, NONALTERABLE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15813966
• MDR Text Key: 303801858
• Report Number: 8030965-2022-09954
• Device Sequence Number: 1
• Product Code: GXN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK - PSI IMPLANTS: TRAUMA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/16/2022
• 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