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

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

Patient Problems Nerve Damage (1979); Unspecified Tissue Injury (4559)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).This report is for an unk - constructs: uss ii/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/ investigation.Initial reporter is a j&j representative.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.The product was not returned.Based on the information available, it has been determined that no corrective and 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: this report is being filed after the review of a clinical evaluation report (cer) from a related research activity database (ddra) for patients undergoing a spinal procedure using uss ii between january 2, 2006, and november 22, 2020.The mean age of the patients was 61 years.Failed spinal procedure has been identified as the reported complication as per icd 9 & 10 categorization experienced by the following with corresponding intervention: intraoperative complications: 12 patients had dural tears; 4 patients had misplaced implants which was adjusted; 2 patients had root injury.Post-op complications within 1 year: 1 patient had pulmonary emblism; 4 patients had deep ssi; 8 patients had superficial ssi; 2 patients had thrombosis; 1 patient had hematoma which was drained.Readmission: 2 patients had adjustment of implants; 1 patient had redecompression; 6 patients had refusion; 2 patient had other reasons; 2 patients had infection which was drained.This is for depuy synthes uss ii.This report is for one (1) unk - constructs: uss ii.This is report 1 of 2 for (b)(4).

• Brand Name: UNK - CONSTRUCTS: USS II
• Type of Device: ORTHOSIS, PEDICLE SPINAL FIXATION
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12732760
• MDR Text Key: 284885977
• Report Number: 8030965-2021-09188
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial
• Report Date: 10/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/06/2021
• 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