MAUDE Adverse Event Report: SYNTHES GMBH UNK - CAGE/SPACERS: ORACLE; INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, LUMBAR

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

Patient Problems Cerebrospinal Fluid Leakage (1772); Decreased Sensitivity (2683)

Event Type  Injury  

Manufacturer Narrative

Additional narrative: 510k: this report is for an unknown cage/spacers: oracle /unknown lot.Part and lot numbers are unknown; udi number is unknown.Reporter is a synthes employee.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.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 spinal surgery.Failed spinal surgery has been identified as the reported complication as per spine tango registry report experienced by the following with corresponding intervention: 2 patients died.General complications - postop surgical before discharge: 1 patient had cardiovascular complications, 1 patient had pulmonary complications, 1 patient had thromboembolism complications, 1 patient had other complications, 1 patient's complications were not documented.Surgical operations - intraop adverse events: 3 patients had dural lesions, 2 patients had vascular injuries, 2 patients had fracture vertebral structures, 2 patients had other complications.Surgical operations - postop surgical before discharge: 1 patient had csf leak/pseudomeningocele, 2 patients had motor dysfunctions, 1 patient had a sensory dysfunction, 11 patients had other complications, 1 patient's complications were not documented.Reoperations: 16 patients had a reoperation because of adjacent segment patology 27 patients had a reoperation because they failed to reach their therapeutic goals, 8 patients had a reoperation because of hardware removal, 29 patients had a reoperation because of instability, 28 patients had a reoperation because of neurocompression, 2 patients had a reoperation because of nonunion, 15 patients had a reoperation because of other reasons, 1 patient had a reoperation because sagittal imbalance, 12 patients had a reoperation because of unknown reasons.This is for depuy synthes spine oracle.This is report 3 of 4 for (b)(4).

• Brand Name: UNK - CAGE/SPACERS: ORACLE
• Type of Device: INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, LUMBAR
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 11214715
• MDR Text Key: 232627822
• Report Number: 8030965-2021-00544
• Device Sequence Number: 1
• Product Code: OVD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/29/2020
• 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
• Patient Outcome(s): Required Intervention