MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: USS; ORTHOSIS, PEDICLE SPINAL FIXATION

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Non-union Bone Fracture (2369); Post Operative Wound Infection (2446); Joint Laxity (4526); Insufficient Information (4580)

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.A1 patient identifier: (b)(6).D1, d2a, d2b, d3, d4, g4 ¿ 510k: this report is for an unknown constructs: uss/unknown lot.Part and lot numbers are unknown; udi number is unknown.D9: complainant part is not expected to be returned for manufacturer review/investigation.E3: reporter is a j&j employee.H3, h4, h6: 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 switzerland as follows: this report is being filed after the review of a clinical evaluation report (cer) from a database related research activity (drra): spine tango soa report - tlif.The following complications have been identified: liver / gi, wound infection deep, wound infection superficial, hardware removal, implant failure, instability, non-union, other, postoperative infection deep, implant failure, wound infection deep.Complication time/intervention: postoperative (before discharge), repeat surgery, sub-acute, 2 - 6 months.This report involves one unk - constructs: uss.This is report 1 of 2 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: USS
• Type of Device: ORTHOSIS, PEDICLE SPINAL FIXATION
• 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: 18450330
• MDR Text Key: 332262771
• Report Number: 8030965-2024-00278
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/12/2023
• Initial Date FDA Received: 01/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: UNK - BIOMATERIAL - CEMENT: VERTECEM
• Patient Outcome(s): Required Intervention