MAUDE Adverse Event Report: SYNTHES GMBH UNK - BIOMATERIAL - PREFORMED: CHRONOS: SPINE; FILLER, CALCIUM SULFATE PREFORMED PELLETS

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Nerve Damage (1979); Non-union Bone Fracture (2369); Osteolysis (2377); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

510k: this report is for an unknown chronos biomaterial/unknown lot.Part and lot number are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.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.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

This report is being filed after the review of a clinical evaluation report (cer) from a related research activity database (ddra) to compare usage and outcomes recorded in 292 patients (148 males, 145 females) for zero-p implants against all other surgical cases recorded within the spine tango registry between (b)(6) 2012 and (b)(6) 2020.Final registry report outcome description: general complications: intraoperative: 1 anaesthesiological.General complications- postoperative surgical before discharge: 1 kidney / urinary, 1 liver / gi, 6 not documented.Surgical complications- intraoperative adverse events: 1 nerve root damage, 3 dural lesion.Surgical complications- postoperative surgical before discharge: 2 other hematoma, 1 radiculopathy, 1 csf leak / pseudomeningocele, 2 motor dysfunction, 1 sensory dysfunction, 2 other, 4 not documented, 1 implant malposition.Reoperations : number of reoperations at any level (27): 6 adjacent segment pathology, 3 failure to reach therapeutic goals, 1 implant failure, 1 instability, 6 neurocompression, 2 non-union, 3 other, 1 sagittal imbalance, 15 unknown.Number of reoperations at the same level (4): 2 failure to reach therapeutic goals, 2 neurocompression, 2 non-union, 1 other.This is for depuy synthes zero-p, pro disc c, prodisc vivo, prodisc-nova and chronos.This report is for one (1) unknown chronos biomaterial.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional narrative: 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 this medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

This report is being filed after the review of a clinical evaluation report (cer) from a related research activity database (ddra) to compare usage and outcomes recorded in 292 patients (148 males, 145 females) for zerop implants against all other surgical cases recorded within the spine tango registry between (b)(6) 2012 and (b)(6) 2020.Final registry report outcome description: general complications: intraoperative 1 anaesthesiological general complications postoperative surgical before discharge 1 kidney / urinary 1 liver / gi 6 not documented surgical complications intraoperative adverse events 1 nerve root damage 3 dural lesion surgical complications postoperative surgical before discharge 2 other hematoma 1 radiculopathy 1 csf leak / pseudomeningocele 2 motor dysfunction 1 sensory dysfunction 2 other 4 not documented 1 implant malposition reoperations : number of reoperations at any level (27) 6 adjacent segment pathology, 3 failure to reach therapeutic goals, 1 implant failure, 1 instability, 6 neurocompression, 2 nonunion, 3 other, 1 sagittal imbalance, 15 unknown.Number of reoperations at the same level (4) 2 failure to reach therapeutic goals.2 neurocompression.2 nonunion.1 other.This is for depuy synthes zerop, pro disc c, prodisc vivo, prodiscnova and chronos.This report is for one (1) unknown chronos biomaterial.

• Brand Name: UNK - BIOMATERIAL - PREFORMED: CHRONOS: SPINE
• Type of Device: FILLER, CALCIUM SULFATE PREFORMED PELLETS
• 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: 11214305
• MDR Text Key: 230937974
• Report Number: 8030965-2021-00541
• Device Sequence Number: 1
• Product Code: MQV
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• 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?: No
• Date Manufacturer Received: 02/21/2024
• 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