MAUDE Adverse Event Report: SYNTHES GMBH UNK - CONSTRUCTS: ZERO-P; ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION

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

Patient Problems Failure of Implant (1924); Nerve Damage (1979); Non-union Bone Fracture (2369); Osteolysis (2377); Joint Laxity (4526); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

Additional narrative: 510 k: this report is for an unk - constructs: zero-p/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is jnj 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.Health effect ¿ clinical code (b)(4) used to capture procedural complications.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) 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 anesthesiologic.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 / pseudo meningocele, 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 neuro- compression, 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 neuro- compression, 2 non-union, 1 other.This is for depuy synthes zero-p, pro disc c, prodisc vivo, prodisc-nova and chronos.The complaint involves 12 devices.Due to a limit of impacted products per complaint, this complaint will be captured under 2 separate complaints as listed below: (b)(4) this complaint will include 10 devices ¿ 5 unk - constructs: zero-p , and 5 unk - biomaterial - preformed: chronos: spine (1st pc).(b)(4) this complaint will include 2 devices ¿1 unk - constructs: zero-p , and 1 unk - biomaterial - preformed: chronos: spine (2nd pc).This report involves one (1) unk - constructs: zero-p.This report is 5 of 6 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.H10: additional narrative: b5 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

Updated event description: this report is being filed after the review of a clinical evaluation report (cer) from a related research activity database (drra) to compare usage and outcomes recorded in 310 patients (148 males, 145 females) for zero-p implants against all other surgical cases recorded within the spine tango registry between 2012 to 2023.The following complications were recorded per country (switzerland) general complications - intraoperative: 1 anaesthesiological general complications - postoperative before discharge: 1 kidney / urinary 1 liver / gi surgical complications - intraoperative: 3 dural lesion 1 nerve root damage surgical complications - postoperative (before discharge): 1 csf leak / pseudomeningocele 2 motor dysfunction 1 other 2 other hematoma 1 radiculopathy 1 sensory dysfunction surgery follow-up complications: early (< 28 days) 1 csf leak/ pseudomeningocele 1 fracture vertebral structures 1 implant failure 1 motor dysfunction 1 other sub-acute (2-6 months) 2 other reoperations: any level: 3 due to adjacent segment pathology 1 due to instability 3 due to neurocompression 1 due to sagittal imbalance 2 due to non-union 2 due to other 15 unknown adjacent level: 1 due to adjacent segment pathology 2 unknown same level: 1 due to adjacent segment pathology 1 due to neurocompression 2 due to non-union 1 due to other the following complications were recorded per country (australia): surgical complications - postoperative before discharge: 1 other the following complications were recorded per country (belgium): surgical complications - postoperative before discharge: 1 implant malposition reoperations: reoperations at any level: 2 due to failure to reach therapeutic goals 1 due to neurocompression 3 due to unknown reoperations at adjacent level: 2 due to failure to reach therapeutic goals 1 due to neurocompression reoperations at same level: 2 due to failure to reach therapeutic goals 1 due to neurocompression.

• Brand Name: UNK - CONSTRUCTS: ZERO-P
• Type of Device: ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 11204757
• MDR Text Key: 232612484
• Report Number: 8030965-2021-00455
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• 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

• 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: 12/29/2020
• Initial Date FDA Received: 01/20/2021
• Supplement Dates Manufacturer Received: 12/21/2023; 12/27/2023
• Supplement Dates FDA Received: 12/27/2023; 12/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention